APEPTICO - Innovation in peptide drugs

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Vienna, 10th August 2023: SARS-CoV2 RBD impairs endothelial ENaC activity, reduces surface hACE2 expression and increases reactive oxygen species (ROS) and tissue factor (TF) generation in monolayers of HL-MVEC, as such promoting barrier dysfunction and coagulopathy. The TNF-derived 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.

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 TIP peptide treatment.

Vienna, 01st 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.

Vienna, 30th 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.

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.

European Innovation Council highlights the APEPTICO story "EU-funded company APEPTICO develops treatment for late-stage COVID-19 patients" https://community-smei.easme-web.eu/articles/stories-eu-funded-company-apeptico-develops-treatment-late-stage-covid-19-patients

Vienna, Austria, 10th October, 2020: APEPTICO Forschung und Entwicklung GmbH has signed the MANIFESTO FOR EU COVID-19 RESEARCH to maximise the accessibility of research results in the fight against COVID-10.

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

Vienna, Austria, 22nd 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).

Vienna, Austria, 4th 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.

Vienna/Austria, Desio/Italy, 28th 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.

Vienna, Austria, 07th 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).

Vienna, Austria, 1st 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.

Vienna, Austria, 12th 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.

15th November, 2018 - APEPTICO, a privately held biotechnology company developing peptide drugs, was represented at the prestigious Keystone Symposium "From Rare to Care: Discovery, Modeling and Translation of Rare Diseases", which took place at the Vienna BioCenter from 11th to 14th November, 2018. Two poster presentations described the latest findings generated by the research collaboration between APEPTICO and the Department of Pharmacology and Toxicology of the University of Vienna.



28th 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.

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.

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).

5th October 2015 - APEPTICO, a privately held biotechnology company developing peptide 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'.

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.

3rd March 2015 - APEPTICO, a privately held biotechnology company developing peptide drugs, today announced that the phase IIa clinical study of AP301-peptide delivered top-line results in the treatment of primary graft dysfunction in patients following lung transplantation.

18th February, 2015 - APEPTICO 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.

2nd January, 2015 - APEPTICO 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).

1st December, 2014 - APEPTICO 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.

16th July, 2014 - APEPTICO today announced that in collaboration with 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).

9th April, 2014 - APEPTICO 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.

7th February, 2014 - APEPTICO announced that it will be participating at BIO-Europe Spring (10th - 12th March, 2014, Turin, Italy). BIO-Europe Spring is the spring counterpart of BIO-Europe, and continues the tradition of providing life science companies with high caliber partnering opportunities. During BIO-Europe Spring, APEPTICO will present preliminary results of its phase IIa clinical study "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 in acute lung injury" to the interested international pharma and biotechnology audience.

23rd October, 2013 - APEPTICO announced that it has entered into a license agreement with Chem Tech Research Incorporation (C-TRI), according to which APEPTICO will provide C-TRI with a non-exclusive license to APEPTICO's database, PEPBASE(TM). Under the terms of the Agreement, APEPTICO will receive a license fee and annual payments from C-TRI for database updates.

8th July, 2013 - APEPTICO 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.

17th April, 2013 - APEPTICO initiates phase II clinical trial with AP301 in patients with primary graft dysfunction following lung transplantation.

31st January, 2013 - APEPTICO 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 - APEPTICO 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 Orphan Product Development (Food and Drug Administration, USA) for the clinical indication "treatment of High Altitude Pulmonary Oedema".

31st August, 2012 - APEPTICO presents clinical results of its inhalation therapy for prevention and treatment of Oedematous Respiratory Failure at the 2012 Annual Congress of the European Respiratory Society.

29th June, 2012 - APEPTICO 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 - APEPTICO completes a EUR 3.4 million financing round.

10th May, 2012 - APEPTICO presents 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.

26th January, 2012 - The patent "Prevention and Treatment of Hyperpermeability" invented and owned by APEPTICO ranks among the 10 most innovative inventions of the year 2011 in Austria.

25th October, 2012 - APEPTICO Announces successful completion of Phase I Trial with AP301 in Oedematous Respiratory Failure.

24th-28th September, 2011 - The Annual Congress of the European Respiratory Society (Amsterdam) has been a major success for APEPTICO's development compound AP301.

9th September, 2011 - APEPTICO 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.

27th-30th June, 2011 - APEPTICO attends the Bio International Convention in Washington DC. APEPTICO exhibits at the Austrian Pavilion #3137 in Hall A and presents latest findings of the AP301 clinical study in the Company Presentation event.

7th April, 2011 - APEPTICO 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.

The 2010 Annual Conference of the European Respiratory Society was a major success for APEPTICO: Three presentations of its lead compound AP301.

Meet APEPTICO at the 2010 Annual Conference of the European Respiratory Society (September 18th - 22nd, 2010) in Barcelona and at the Bio-Europe in Munich (November 15th - 17th, 2010).

1st July, 2010 - APEPTICO's lead molecule AP301 has been validated in the porcine model of lung injury by inhalation of the peptide-aerosol.

5th August, 2010 - APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs, today announced completion of a €3 million financing round.

23rd February, 2010 - APEPTICO's lead molecule AP301 has been validated in the experimental lung transplantation model to prevent ischemia reperfusion injury.

10th February, 2010 - APEPTICO granted Orphan Drug Designation by FDA for development compound AP301.

APEPTICO will present the company and development products at the BioSquare (February 1st-2nd, 2010) and Bio-Europe Spring (March 8th-10th, 2010).

Meet APEPTICO at the Science4Life Messe in Frankfurt (October 22nd, 2009) and the Bio-Europe in Vienna (November 2nd-4th, 2009).

8th September, 2009 - APEPTICO presents its lead product AP301 at the Annual Congress of the European Respiratory Society in Vienna, Austria.

20th July, 2009 - APEPTICO granted Orphan Medicinal Product Designation by EMEA for lead product AP301.