APEPTICO - Innovation in peptide drugs

The SOLNATIDE animation video is available at youtube:

https://www.youtube.com/watch?v=xFDRaoM_2S0

Vienna, 10th August 2023: APEPTICO's SOLNATIDE peptide (a.k.a. TIP, AP301) -which directly activates ENaC upon binding to its a subunit- can override RBD-induced impairment of ENaC function and hACE2 expression, mitigates ROS and TF generation and restores barrier function in HLMVEC monolayers. The Receptor-Binding-Domain (RBD) is part of the S1 subunit of the spike protein of SARS-CoV2.

In correlation with the increased mortality observed in COVID-19 patients co-infected with S. pneumoniae, compared to subjects solely infected with SARS-CoV2, we observe that prior intraperitoneal RBD treatment in transgenic mice globally expressing hACE2 significantly increases fibrin deposition and capillary leak upon intratracheal instillation of S. pneumoniae and that this is mitigated by SOLNATIDE peptide treatment.

Vienna, 01^st November 2022: In an antigen-induced arthritis model, solnatide peptide reduced cell influx and release of pro-inflammatory mediators into the joints, associated with reduction in oedema and tissue damage, as compared to controls indicating that the TNF-derived lectin-like solnatide peptide has anti-inflammatory effects in an acute model of joint inflammation, APEPTICO Forschung und Entwicklung GmbH today announced.

More recently, it was demonstrated that the solnatide peptide improves lung function in acutely inflamed lungs in both animal models of acute respiratory distress syndrome (ARDS) and in ARDS patients upon binding to the alpha subunit of the epithelial sodium channel (ENaC), which can be expressed in both epithelial and endothelial cells. Solnatide (a.k.a. TIP peptide, AP301) has also been shown to protect kidneys and to exert potent anti-inflammatory activity in an experimental glomerulonephritis model.

Scientists from the Universidade Federal do Ceará (Fortaleza, Brazil), the Universidade Federal de Minas Gerais (Belo Horizonte, Brazil), the Medical College of Georgia at Augusta University (Augusta, USA), the Friedrich-Alexander-University Erlangen-Nürnberg (Erlangen, Germany) and APETICO Forschung und Entwicklung GmbH (Vienna, Austria) investigated whether TNF-receptor-independent activities of TNF, such as those mediated by the TNF-derived solnatide peptide, which mimics the lectin-like domain, are protective in an immune-mediated arthritis mouse model.

The data published on 31^st October 2022 in Frontiers in Immunology (https://doi.org/10.3389/fimmu.2022.1049368) for the first time demonstrate that solnatide significantly reduces inflammatory cell infiltration and joint damage in an immune-mediated experimental arthritis model in mice. The effect of solnatide was observed using both prophylactic and therapeutic strategies and following local (intra-articular) and systemic (intravenous) administration. Solnatide actions were also associated with a reduction in proinflammatory cytokine (IL-1b and IL-6) and chemokine (CCL2 and CXCL-1) levels in joint exudates.

Vienna, 30^th May 2022: APEPTICO Forschung und Entwicklung GmbH today announced that the 3-D structure and the mechanism of action of solnatide, a possible treatment for pulmonary oedema, has been disclosed by an international network of scientists led by APEPTICO.

Pulmonary permeability oedema is a life-threatening accumulation of fluid in the lungs, due to capillary leak either combined or not with impaired lung fluid clearance. It causes lack of oxygenation of the blood and can occur in patients with the Acute Respiratory Distress Syndrome (ARDS), which is the major complication in patients with severe COVID-19. The accumulation of liquid inside the lung’s airspace is linked to defects in the functioning of the epithelial sodium channel (ENaC), which can be induced by bacterial and viral toxins, including the spike protein of SARS-CoV-2. Pulmonary permeability oedema and lung tissue inflammation significantly contribute to the high mortality rate observed in patients with severe ARDS and severe COVID-19. Both of these medical conditions require invasive mechanical ventilation (IMV) and intensive care treatment.

The three-dimensional structural analysis of solnatide was led by Dr. Maria Macias, ICREA researcher and head of the Structural Characterization of Macromolecular Assemblies lab at IRB Barcelona, in collaboration with the APEPTICO scientific team and built upon earlier findings from Dr. Douglas Eaton’s (Emory) and Dr. Rudolf Lucas’ (Augusta University) research groups. Solnatide was manufactured by BCN Peptides in Barcelona.

Based on the conformational studies and in the analysis of charge distribution of the solnatide peptide surface, which has been published in the Computational and Structural Biotechnology Journal, the collaborators propose a model to describe how the solnatide peptide may interact with the cytoplasmic C-terminal domain of the ENaC-α subunit via electrostatic complementarity.

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Vienna, April 2022. In collaboration with the team of investigators, the clinical study protocol and interim data for the treatment of moderate to severe COVID-19 patients have been published in TRIAL Journal.

Schmid B, Kredel M, Ullrich R, Krenn K, Lucas R, Markstaller K, Fischer B, Kranke P, Meybohm P, Zwißler B, Frank S.  Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate-to-severe ARDS—a randomized, placebo-controlled, double-blind trial. Trials (2021) 22:643.

Schmid B, Kredel M, Ullrich R, Krenn K, Lucas R, Markstaller K, Fischer B, Kranke P, Meybohm P, Zwißler B, Frank S.  Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate-to-severe ARDS—a randomized, placebo-controlled, double-blind trial. Trials (2021) 22:643.

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Vienna, Austria, 24^nd August, 2020: APEPTICO Forschung und Entwicklung GmbH today announced that its global survey on incidence of ARDS and outcomes in hospitalized patients with COVID-19 has been published by Critical Care.

Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) appeared just over 7 months ago in Wuhan, China. Early reports indicated that although some cases are asymptomatic, 20% of COVID-19 cases follow a severe course, necessitating hospitalization, with a quarter of hospitalized patients requiring intensive care unit (ICU) facilities. Later reports substantiated these data, although ICU admission rates, proportion of patients receiving invasive mechanical ventilation (IMV), and mortality rates differ considerably between studies.

 Acute respiratory distress syndrome (ARDS) is a frequent and life-threatening complication in COVID-19. Patients with moderate-to severe ARDS require invasive mechanical ventilation (IMV) and have a poor prognosis.

 APEPTICO’s global survey resulted that among hospitalized COVID-19 patients, approximately 1/3 (33%) develop ARDS, 1/4 (26%) require transfer to an ICU, 1/6 (16%) receive IMV, and 1/6 (16%) die. For COVID-19 patients transferred to an ICU, nearly 2/3 (63%) receive IMV and 3/4 (75%) have ARDS. The mortality rate of ICU COVID-19 patients is 40% and of those who receive IMV 59%; the mortality rate in COVID-19-associated ARDS is 45%, and the incidence of ARDS among non-survivors of COVID-19 is 90%, despite increasing use of anti-viral therapies.

Vienna, Austria, 22^nd June, 2020: APEPTICO Forschung und Entwicklung GmbH today announced that it has been nominated one of the most innovative companies in the categories medicines and organic chemistry in Austria by the Society for Consumer Studies (ÖGVS, Gesellschaft für Verbraucherstudien mbH).

In the Innovations-Award 2020/2021 survey conducted by the ÖGVS, a member of the Consumer Guidance Group, APEPTICO ranks top in innovation power in the IPC classes A61 (Medical Science) and C07 (Organic Chemistry) in Austria following a detailed analysis of its patent and innovation status. In both categories, APEPTICO received scores far above average, and is within the 10 most innovative companies in these areas.

Vienna, Austria, 4^th May, 2020: APEPTICO Forschung und Entwicklung GmbH today announced that it has supplied its Investigational Medicinal Product solnatide to the Medical University Vienna for the assessment of efficacy in COVID-19 patients. The Department of Clinical Pharmacology has initiated a Phase II placebo controlled randomised study to explore the efficacy of solnatide IMP in SARS-CoV-2 positive patients with moderate-to-severe ARDS and pulmonary permeability oedema.

APEPTICO is a privately-held biotechnology company from Vienna/Austria, developing peptide-based medicinal products to treat life-threatening pulmonary dysfunctions, such as severe respiratory failure, oedematous respiratory failure (lung oedema), acute respiratory distress syndrome (ARDS), primary graft dysfunction (PGD) following lung transplantation, high altitude pulmonary oedema (HAPE) and pseudohypoaldosteronism type 1B (PHA1B).

Clinical data gathered so far from hospitalised patients suffering from COVID-19 have revealed that 20% suffer from ARDS, and the involvement of pulmonary oedema is evidenced by post-mortem sampling of a patient who succumbed to COVID-19 infection. The observed mortality rate for ARDS ranges from 16% to 60%. At present no medicine has been approved specifically for the therapeutic treatment of ARDS and pulmonary permeability oedema in ARDS.

APEPTICO’s lead compound, the therapeutic molecule solnatide (INN) is being developed by APEPTICO for the treatment of various forms of life-threatening acute pulmonary dysfunction and pulmonary oedema in ARDS patients. In 2013, APEPTICO successfully completed a phase I clinical study in healthy subjects, proving the safety of solnatide. APEPTICO subsequently successfully completed two phase II clinical studies, one a randomized, double-blinded placebo-controlled trial using inhaled solnatide in mechanically-ventilated ARDS patients with lung oedema, the other a randomized, placebo-controlled pilot study in patients suffering from primary graft dysfunction (PGD) following lung transplantation.

Commenting on the agreement with the Medical University Vienna, Bernhard Fischer, CEO of APEPTICO, stated: "We are very happy supplying our solnatide development drug to the Department of Clinical Pharmacology of the Medical University Vienna. According to the EU Clinical Trials Register, APEPTICO’s solnatide IMP is the only active ongoing campaign against ARDS in the Europe which assesses an innovative and new therapeutic compound that already delivered proof-of-concept results in two clinical studies in patients with severe lung dysfunctions.”

The clinical study at the Medical University Vienna has been submitted for co-funding within the framework of the Corona Emergency Call to the Austrian Research Promotion Agency (FFG).

Vienna/Austria, Desio/Italy, 28^th April 2020: APEPTICO Forschung und Entwicklung GmbH and OPIS srl today announced that the solnatide IMP has been approved within the compassionate use program of drugs undergoing clinical trials for treatment of COVID-19 patients suffering from pulmonary permeability oedema and acute respiratory distress syndrome (ARDS) by the Italian Medicines Agency and the Ethics Committee of the National Institute for Infectious Diseases Lazzaro Spallanzani.

APEPTICO is a privately-held biotechnology company from Vienna/Austria, developing peptide-based medicinal products to treat life-threatening pulmonary dysfunctions, such as severe respiratory failure, oedematous respiratory failure (lung oedema), acute respiratory distress syndrome (ARDS), primary graft dysfunction (PGD) following lung transplantation, high altitude pulmonary oedema (HAPE) and pseudohypoaldosteronism type 1B (PHA1B).

OPIS is a full-service Contract Research Organization (CRO) founded in 1998 in Italy, providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.

Clinical data gathered so far from hospitalised patients suffering from COVID-19 have revealed that 20% suffer from life-threatening pulmonary dysfunctions such as ARDS (acute respiratory distress syndrome), and the involvement of pulmonary oedema is evidenced by post-mortem sampling of patients who succumbed to COVID-19 infection. The observed mortality rate for ARDS ranges from 16% to 60%. At present no medicine has been approved specifically for the therapeutic treatment of ARDS, pulmonary permeability oedema, as well as ARDS in COVID-19 patients.

APEPTICO’s lead compound, the therapeutic molecule solnatide (INN) is being developed by APEPTICO for the treatment of various forms of life-threatening acute pulmonary dysfunction and pulmonary oedema in ARDS patients. Previously, solnatide has been assessed for safety and tolerability in a phase I clinical study in healthy subjects, and for preliminary efficacy two phase II clinical studies in mechanically-ventilated patients with acute respiratory distress syndrome (ARDS) and in patients suffering from primary graft dysfunction (PGD) following lung transplantation.

Commenting on the approval of solnatide by the Italian Medicine Agency (Agenzia Italiana del Farmaco -AIFA) and the Italian National Ethics Committee, Bernhard Fischer, CEO of APEPTICO, stated: "After the initial approval in Austria, this is the second European country approving solnatide for the emergency treatment of severely injured COVID-19 patients. Together with OPIS we will make solnatide available for COVID-19 patient treatment in Italy, one of the European Countries most affected by the new coronavirus infections.”

Aldo Poli, CEO of OPIS added: “We are proud to participate to the clinical development of solnatide in patient affected with COVID-19. At this time of great difficulty on a global level, OPIS is pleased to be at the forefront of the fight against coronavirus, collaborating with APEPTICO with the aim of providing a new therapeutic approach in patients with COVID-19 who develop respiratory complications.”

Vienna, Austria, 07^th April, 2020: APEPTICO Forschung und Entwicklung GmbH today announced that its solnatide IMP has been approved for Compassionate Use by the Austrian Federal Office for Safety in Health Care (BASG) for the treatment of patients infected by the novel coronavirus SARS-CoV-2 and subsequently developing severe pulmonary dysfunction (severe COVID-19).

 APEPTICO is a privately-held biotechnology company from Vienna/Austria, developing peptide-based medicinal products to treat life-threatening pulmonary dysfunctions, such as severe respiratory failure, oedematous respiratory failure (lung oedema), acute respiratory distress syndrome (ARDS), primary graft dysfunction (PGD) following lung transplantation, high altitude pulmonary oedema (HAPE) and pseudohypoaldosteronism type 1B (PHA1B).

 Clinical data gathered so far from hospitalised patients suffering from COVID-19 have revealed that 20% suffer from life-threatening pulmonary dysfunctions such as ARDS (acute respiratory distress syndrome), and the involvement of pulmonary oedema is evidenced by post-mortem sampling of patients who succumbed to COVID-19 infection. The observed mortality rate for ARDS ranges from 16% to 60%. At present no medicine has been approved specifically for the therapeutic treatment of ARDS, pulmonary permeability oedema, as well as ARDS in COVID-19 patients.

 APEPTICO’s lead compound, the therapeutic molecule solnatide (INN) is being developed by APEPTICO for the treatment of various forms of life-threatening acute pulmonary dysfunction and pulmonary oedema in ARDS patients. In 2013, APEPTICO successfully completed a phase I clinical study in healthy subjects, proving the safety of solnatide. APEPTICO subsequently successfully completed two phase II clinical studies, one a randomized, double-blinded placebo-controlled trial using inhaled solnatide in mechanically-ventilated ARDS patients with lung oedema, the other a randomized, placebo-controlled pilot study in patients suffering from primary graft dysfunction (PGD) following lung transplantation.

 Commenting on the approval of solnatide by the Austrian Federal Office for Safety in Health Care (BASG), Bernhard Fischer, CEO of APEPTICO, stated: "In this emergency situation, we have submitted all relevant data to the BASG for review. We are very honoured that the BASG has approved solnatide for the treatment of severely injured COVID-19 patients. According to our records this is a first-time approval of an innovative drug from Austria for the treatment of SARS-CoV-2 induced acute lung dysfunction (ARDS) in severely affected COVID-19 patients. APEPTICO will continue taking its social responsibility in the fight against the novel coronavirus”, he added.

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Vienna, Austria, 1^st April, 2020: APEPTICO Forschung und Entwicklung GmbH today announced that it has signed, together with the “solnatide consortium”, the Grant Agreement with the European Commission to accelerate the process of making APEPTICO’s proprietary investigational medicinal product (IMP) solnatide available for medical treatment of patients severely affected by the novel coronavirus 2019 (SARS-CoV-2) disease, COVID-19.

APEPTICO is a privately-held biotechnology company based in Austria, developing peptide-based medicinal products to treat life-threatening pulmonary dysfunctions, such as severe respiratory failure, oedematous respiratory failure (lung oedema), acute respiratory distress syndrome (ARDS), primary graft dysfunction (PGD) following lung transplantation, high altitude pulmonary oedema (HAPE) and pseudohypoaldosteronism type 1B (PHA1B).

APEPTICO’s lead compound, the therapeutic molecule solnatide (INN) is being developed by APEPTICO for the treatment of various forms of life-threatening acute pulmonary dysfunction and pulmonary oedema in ARDS patients. In 2013, APEPTICO successfully completed a phase I clinical study in healthy subjects, proving the safety of solnatide. APEPTICO subsequently successfully completed two phase II clinical studies, one a randomized, double-blinded placebo-controlled trial using inhaled solnatide in mechanically-ventilated ARDS patients with lung oedema, the other a randomized, placebo-controlled pilot study in patients suffering from primary graft dysfunction (PGD) following lung transplantation.

Clinical data gathered so far from hospitalised patients suffering from COVID-19 have revealed that 20% suffer from ARDS and the involvement of pulmonary oedema is evidenced by post-mortem sampling of a patient who succumbed to COVID-19 infection. The observed mortality rate for ARDS is 20-30%. At present no medicine has been approved specifically for the therapeutic treatment of pulmonary permeability oedema or ARDS.

The Grant Agreement was made available via the Horizon2020  programme “Advancing knowledge for the clinical and public health response to the 2019-nCoV epidemic” (https://ec.europa.eu/commission/presscorner/detail/en/ip_20_386).

In this emergency situation in hospitals across Europe, APEPTICO will make solnatide IMP available for the acute and therapeutic treatment of patients suffering from severe symptoms of infection with the SARS-CoV-2 novel coronavirus.

Commenting on the EU Grant Agreement, Bernhard Fischer, CEO of APEPTICO, stated: "We are very happy that the European Commission agreed with APEPTICO and the “solnatide-consortium” to financially support us in the consortium’s effort to make solnatide IMP available for the treatment of severely affected patients with the new coronavirus. By offering our solnatide IMP for the immediate treatment of patients, APEPTICO commits its responsibilities towards the society.”

Vienna, Austria, 12^th March, 2020: APEPTICO Forschung und Entwicklung GmbH today announced that it has been invited together with its consortium by the European Commission through the Horizon 2020 research and innovation programme to start the grant preparation to make APEPTICO’s proprietary investigational medicinal product (IMP) solnatide available for medical treatment of patients severely affected by novel coronavirus 2019 (2019-nCoV) disease, COVID-19.

 APEPTICO is a privately-held biotechnology company based in Austria, developing peptide-based medicinal products to treat life-threatening pulmonary dysfunctions, such as severe respiratory failure, oedematous respiratory failure (lung oedema), acute respiratory distress syndrome (ARDS), primary graft dysfunction (PGD) following lung transplantation, high altitude pulmonary oedema (HAPE) and pseudohypoaldosteronism type 1B (PHA1B).

 APEPTICO’s lead compound, the therapeutic molecule solnatide (INN) is being developed by APEPTICO for the treatment of various forms of life-threatening acute pulmonary dysfunction and pulmonary oedema in ARDS patients. In 2013, APEPTICO successfully completed a phase I clinical study in healthy subjects, proving the safety of solnatide. APEPTICO subsequently successfully completed two phase II clinical studies, one a randomized, double-blinded placebo-controlled trial using inhaled solnatide in mechanically-ventilated ARDS patients with lung oedema, the other a randomized, double-blinded placebo-controlled trial study in patients suffering from primary graft dysfunction (PGD) following lung transplantation.

 Clinical data gathered so far from hospitalised patients suffering from COVID-19 have revealed that 20% suffer from ARDS and the involvement of pulmonary oedema is evidenced by post-mortem sampling of a patient who succumbed to COVID-19 infection. The known mortality rate for ARDS is 20-30%. At present no medicine has been approved specifically for the therapeutic treatment of pulmonary permeability oedema or ARDS.

 Within the scope of the Horizon2020 “Advancing knowledge for the clinical and public health response to the 2019-nCoV epidemic” (https://ec.europa.eu/commission/presscorner/detail/en/ip_20_386) APEPTICO’s  program proposal was ranked among the top applicants. According to the objective of the call, APEPTICO will use its capacity and expertise to immediately explore the efficacy of solnatide IMP as a therapy for COVID-19. Furthermore, in this emergency situation in hospitals across Europe, APEPTICO will make solnatide IMP available for the acute and therapeutic treatment of patients suffering from severe symptoms of infection with the 2019-nCoV novel coronavirus.

 Commenting on the EU Grant invitation, Bernhard Fischer, CEO of APEPTICO, stated: "We are very happy that the European Commission has recognised the clinical potential of solnatide for the treatment of severely affected patients with the new coronavirus. By offering our solnatide IMP for the immediate treatment of patients, APEPTICO commits its responsibilities towards the society.”

Vienna, 23rd October, 2018: The latest findings and results emanating from the research collaboration between APEPTICO and the Department of Pharmacology and Toxicology of the University of Vienna will be presented in two posters at the upcoming conference, "From Rare to Care: Discovery, Modeling and Translation of Rare Diseases", taking place at the Vienna BioCenter from 11th to 14th November, 2018.

The poster themes deal with different aspects of development of APEPTICO's lead compound, the cyclic peptide solnatide, as an orphan drug. One poster will present encouraging results obtained from in vitro studies demonstrating that solnatide and a congener, AP318, rescue loss-of-function mutations in the epithelial sodium channel, ENaC, thus indicating that these so-called TIP peptides are a potential therapy for the life-threatening orphan disease, systemic pseudohypoaldosteronism (PHA1B).  (PHA1B is caused by loss-of-function mutations in the genes SCNN1A, SCNN1B and SCNN1G, which code for ENaC subunits). The second poster deals with some of the challenges facing a small biopharmaceutical proposing to develop a potential therapy for an orphan disease.

Vienna, Austria, 28^th July 2017: APEPTICO, a privately held biotechnology company developing peptide drugs, today announced it has received a FemPower Award sponsored by the City of Vienna.

During a City of Vienna-open business & project competition, the APEPTICO team has applied for the prestigious “FemPower Award”. The “FemPower Award” makes special recognition to female team-leaders and project-members in science and industry. Within the applied project, Dr. Susan Tzotzos from APEPTICO has taken the role of the project co-ordinator. With the FemPower call, research projects are supported which are either directed by women or whose implementation is decisively performed by women. The “FemPower Award” also recognised APEPTICO’s yearlong collaboration with the research group of Prof. Dr. Rosa Lemmens-Gruber from the Department of Pharmacology and Toxicology of the University Vienna.

APEPTICO is using the non-diluting and non-refundable grant to strengthening the scientific collaboration with the Department of Pharmacology and Toxicology of the University Vienna. The joined scientific research team of APEPTICO and the Department of Pharmacology and Toxicology the University Vienna explorse additional medical therapeutic application of Solnatide, a highly specific sodium ion channel modulator.

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Vienna, Austria and Milano, Italy, 2^nd December 2016 - Apeptico Forschung und Entwicklung GmbH and Mediolanum farmaceutici S.p.A. today announce the signing of a Research & Development Cooperation and License Agreement for Apeptico's compound solnatide. Solnatide is a therapeutic peptide developed by Apeptico for the activation of alveolar liquid clearance, ready to enter into phase IIb clinical development for different life-threatening pulmonary indications.

Under the Agreement, Apeptico will receive an up-front research & development payment in cash, development milestones, and will supply Mediolanum the finished pharmaceutical product. In return, Mediolanum will receive an exclusive license for solnatide for various European markets.

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Vienna, Austria and Milano, Italy, 2nd December 2016 - Apeptico Forschung und Entwicklung GmbH and Mediolanum farmaceutici S.p.A. today announce the signing of a Research & Development Cooperation and License Agreement for Apeptico's compound solnatide. Solnatide is a therapeutic peptide developed by Apeptico for the activation of alveolar liquid clearance, ready to enter into phase IIb clinical development for different life-threatening pulmonary indications.

Vienna, Austria, 15th November 2016: APEPTICO, a privately held biotechnology company developing peptide drugs, today announced that in collaboration with Professor Zhou Qiquan from the Medical University in Chongqing it has produced breakthrough scientific results for the use of solnatide for the treatment of High Altitude Pulmonary Oedema (HAPE).

9th February 2016, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a
biotechnology company developing novel peptide-based drugs, today announced that its
development compound Solnatide has been granted Orphan Drug Designation for
"Treatment of Primary Graft Dysfunction following Lung Transplantation" and for
"Treatment of Pseudohypoaldosteronism Type 1B" by the Food and Drug Administration.

1st December 2015, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs, today announced that its development compounds AP301 (INN: Solnatide) and AP318 have been granted orphan drug designation by the Committee for Orphan Medicinal Products of the European Medicines
Agency for treatment of Pseudohypoaldosteronism Type 1B.

5th October 2015, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs, today announced that its development compound AP301 has been granted orphan drug designation by the Committee for Orphan Medicinal Products of the European Medicines Agency for the orphan indication ‘treatment of primary graft dysfunction following lung transplantation'.

Vienna, Austria, 1st June 2015: APEPTICO, a privately held biotechnology company developing peptide drugs, today announced that it has succeeded in the technical development of carrier-free protein-only dry powder inhalation particles.
Vienna, Austria, 3rd March 2015: APEPTICO, a privately held biotechnology company developing peptide drugs, today announced that the phase IIa clinical study of AP301-peptide delivered topline results in the treatment of primary graft dysfunction in patients following lung transplantation.

Vienna, Austria, 18th February 2015: APEPTICO, a privately-held biotechnology company
developing synthetic protein structures, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed the phase III clinical development strategy for APEPTICO's AP301-peptide in the orphan condition Acute Respiratory Distress Syndrome.

Vienna, Austria, 2nd January 2015: APEPTICO, a privately-held biotechnology company developing synthetic protein structures, today announced that it has been awarded a research grand by the Wellcome Trust under the Pathfinder Award scheme to further explore the role of APEPTICO's compound ‘Enaritide' for the treatment of Pseudohypoaldosteronism type 1b (PHA type 1b).

Vienna, Austria, 1st December 2014: APEPTICO, a privately-held biotechnology company developing peptide drugs, today announced that it will present major scientific break-through results for its AP301-peptide based inhalation medicine at leading international conferences in December this year.

Vienna, Austria, September 16th, 2014. Most recently, in a scientific collaboration effort between APEPTICO, the Vascular Biology Center of the Georgia Regents University (Prof. Dr. Rudolf Lucas, USA), and the Institute of Pharmacology and Toxicology of the University of Vienna (Prof. Dr. Rosa Lemmens-Gruber, Austria), the detailed mechanism has been discovered how APEPTICO's clinically stage "AP301-peptide" (identical to the lectin-like domain of native TNF-alpha) activates the specific pulmonary ion channel "ENaC" to result in "Activation of Lung Oedema Clearance".

Vienna, Austria, 16th July, 2014: APEPTICO, a privately held biotechnology company developing peptide drugs, today announced that Dr. Rudolf Lucas, co-founder of APEPTICO and Professor of Pharmacology and Toxicology at the Vascular Biology Center, Medical College of Georgia, Georgia Regents University, has produced breakthrough results in the scientific understanding of alveolar liquid clearance regulation by the apically expressed pulmonary epithelial sodium channel (ENaC).
Vienna, Austria, April 9th, 2014: APEPTICO, a privately held biotechnology company developing peptide drugs, today announced that the phase IIa clinical study of AP301 delivered top-line results in the treatment of pulmonary permeability oedema in mechanically ventilated patients suffering from Acute Respiratory Distress Syndrome.

Vienna, Austria, March 13th, 2014: APEPTICO, a privately-held biotechnology company developing peptide drugs, today announced that the target selection team at Global Medical Discovery has identified our publication "Mechanism of Action of Novel Lung Edema Therapeutic AP301 by Activation of the Epithelial Sodium Channel" as a key scientific article contributing to excellence in biomedical research.

Vienna, Austria, December 3rd, 2013: APEPTICO, a privately-held biotechnology company developing peptide drugs, today announced that significant scientific results of its development compound AP301 have been published in Molecular Pharmacology and The Journal of Clinical Pharmacology, summarising the mode of action of AP301 in activating the amiloride-sensitive epithelial sodium ion channel (ENaC) and presenting the results of APEPTICO's first-in-man clinical study of orally inhaled AP301.

Vienna, Austria, October 23, 2013 - APEPTICO, a privately-held biotechnology company developing peptide drugs, today announced that it has entered into a license agreement with Chem Tech Research Incorporation (C-TRI), where APEPTICO will provide C-TRI with a non-exclusive license to APEPTICO's database PEPBASE(TM). Under terms of the Agreement, APEPTICO will receive a license fee and annual payments from C-TRI for data base updates.

Vienna, Austria, July 8, 2013 - APEPTICO, a privately-held biotechnology company developing peptide drugs based on its PEPBASE^TM discovery technology, today announced that it has received a research grant worth more than EUR 500,000 from the Austrian Research Promotion Agency (FFG) to accelerate the clinical assessment of the AP301 peptide in patients following lung transplantation.

Vienna, Austria, April 17, 2013 - APEPTICO, a privately-held biotechnology company developing peptide drugs based on its PEPBASE^TM discovery technology, today announced that the Ethics Committee of the Medical University of Vienna has approved the company's application to perform a phase IIa clinical study in male and female patients following lung transplantation to investigate the clinical effect of repetitive orally inhaled doses of AP301 on primary graft dysfunction.

Vienna, Austria, 31st January, 2013: Apeptico Forschung und Entwicklung GmbH announced that the recent publication of an article in the journal Pulmonary Pharmacology and Therapeutics, describing the effect of APEPTICO's lead compound, AP301, in primary dog, pig and rat cells, marked the culmination of another successful year in the Company's R&D programme.

18th January, 2013, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs, today announced that its development compound AP301 has been granted orphan-drug designation by the Committee for Orphan Medicinal Products (European Medicines Agency, EC) and by the Office of
rphan Product Development (Food and Drug Administration, USA) for the clinical indication "treatment of High Altitude Pulmonary Oedema".

31st August, 2012, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs for the treatment of life threatening lung diseases today announced that it will present most recent clinical research results of its inhalation therapy for prevention and treatment of Oedematous Respiratory Failure at the 2012 Annual Congress of the European Respiratory Society.

Vienna, Austria, June 29, 2012 - APEPTICO, a privately-held biotechnology company developing peptide drugs based on its PEPBASE^TM discovery technology, today announced the initiation of a proof of concept study in male and female intensive care patients to investigate the clinical effect of repetitive orally inhaled doses of AP301 on alveolar liquid clearance.

16th May, 2012, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs, today announced completion of a EUR 3.4 million financing round. This equity financing combined existing and new private and institutional investors, as well as a research grant from the Austrian Research
Promotion Agency (FFG).

10th May, 2012, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs for the treatment of life threatening lung diseases today announced that it will present early clinical development results of its inhalation therapy for prevention and treatment of oedematous respiratory failure at the 2012 International Conference of the American Thoracic Society.

Vienna, Austria, 26th January, 2012- The patent "Prevention and Treatment of Hyperpermeability" invented and owned by APEPTICO GmbH ranks among the 10 most innovative inventions of the year 2011 in Austria. Today, APEPTICO's patent AT_507_953 was awarded the INVENTUM nomination based on a decision of a jury composed of patent experts of the Austrian Patent Office and the Federal Ministry for Transport, Innovation and Technology.

Vienna, Austria, 25th October, 2011- APEPTICO GmbH, a biotechnology company developing peptide drugs based on its PEPBASE^TM discovery technology, today announced completion of a Phase I clinical trial for its pulmonary sodium ion channel activator AP301. The orally inhaled drug candidate was safe and well-tolerated by all study participants. AP301 is being developed for the prevention and treatment of oedematous respiratory failure in patients suffering from lung infection, lung injury and lung transplantation.

29th September, 2011, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs for the treatment of life threatening lung diseases today announced that the 2011 Annual Conference of the European Respiratory Society has been a major success for the company.

9th September, 2011, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs for the treatment of life threatening lung diseases today announced that it will present significant research results of its inhalation therapy for prevention and treatment of Oedematous Respiratory Failure at the 2011 Annual Congress of the European Respiratory Society.

Vienna, Austria, April 07, 2011 - APEPTICO, a privately-held biotechnology company developing peptide drugs based on its PEPBASE^TM discovery technology, today announced the initiation of a Phase I clinical trial with its lead product AP301 to assess the safety and tolerability of the orally inhaled peptide drug. AP301 is being developed for the treatment of oedematous respiratory failure in patients suffering from lung
infection, lung injury and lung transplantation.

5th August, 2010, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs, today announced completion of a €3 million financing round. This equity financing combined existing and new investors from Germany and Switzerland. As an integral part of the financing round, APEPTICO will receive a €1.2 million research grant from the Austrian Research Promotion Agency (FFG).

23rd February, 2010, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs, today announced that it's lead molecule AP301 has been validated in an experimental lung transplantation model where intratracheal application of AP301 dramatically improved oxygenation after lung transplantation.

10th February, 2010, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs, today announced that it has received Orphan Dug Designation in the USA from the Food and Drug Administration (FDA) for APEPTICO's development compound AP301. AP301 has been granted Orphan Drug Designation in the USA for "prevention of ischemia reperfusion injury in the lung during lung transplantation".

15th September, 2010, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology compan developing a novel peptide-based drug for the treatment of the life threatening disease "Acute Lung Injury" today announced, that it will present its inhalation therapy for prevention and treatment of Acute Lung Injury at the Annual Congress of the European Respiratory Society which starts on 18th September 2010 in Barcelona, Spain.

1st November September, 2009, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing the novel peptide-based drug AP301 for the treatment of the life threatening disease "Acute Lung Injury", announced today that it will participate at the 15th BIO-Europe International Partnering Conference which starts on 2nd November 2009 in Vienna, Austria. APEPTICO will be in the Austrian Biotech Pavilion conducting pre-scheduled face-to-face meetings.

8th September, 2009, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing a novel peptide-based drug for the treatment of the life threatening disease "Acute Lung Injury" today announced, that it will present its most recent scientific results for APEPTICO's lead compound AP301 at the Annual Congress of the European Respiratory Society which starts on 12th September 2009 in Vienna, Austria.

20th July, 2009, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs, today announced that it has received Orphan Medicinal Product Designation in the European Union from the European Medicines Agency (EMEA) for APEPTICO's lead product AP301 ("Human tumour necrosis
factor alpha-derived peptide") for the "treatment of Acute Lung Injury".

9th June 2009, Wien, Österreich: APEPTICO Forschung und Entwicklung GmbH teilt mit, dass das Unternehmen anlässlich der Verleihung des "Venture Capital & Private Equity Award Österreichs" mit einem Preis ausgezeichnet wurde. Dieser Preis wurde durch den „Styria Börse Express" und die „Junge Industrie" verliehen und stellt eine Anerkennung für die kürzlich abgeschlossene Finanzierung des Unternehmens durch Investoren und Österreichische Fördergeber dar.

29th May, 2009, Vienna, Austria: APEPTICO, a biotechnology company developing novel peptide-based drugs, announced completion of a seed financing round. The EUR 1 Mio equity financing round was led by The BioScience Ventures Group AG (BSVG, www.bsvg.com, Munich/Germany) and included the participation of the Swiss business angel Dr. Jürg Geigy. Both, BSVG and Dr. Geigy are specialised in early stage investments in the biotech industry. The completion of the financing round entitled APEPTICO to receive a grant of EUR 1.2 Mio from the Austrian Research Promotion Agency (FFG).

March 26th, 2009, Venna, Austria. Medical breakthrough for treatment of Acute Lung Injury. Based on intensive research and comprehensive in-vitro and in-vivo studies APEPTICO Forschung und Entwicklung GmbH, a Vienna development stage biotechnology company, has clarified the mode of action of its development compound AP301. Up to date there exists no approved drug molecule for the treatment of Acute Lung Injury. Up to 100,000 patients in Europe could benefit from the new discovery.