APEPTICO - Innovation in peptide drugs

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.

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.

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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APEPTICO 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).

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).

In a complex animal study, conducted in climate chambers simulating ascent to a mountain altitude of 6,000 meters, and continuation of exposure of test animals for several days to both hypobaric and hypoxic high altitude conditions, it has been demonstrated that solnatide reduced pulmonary oedema, increased occludin expression and improved gas-blood barrier function during acute hypobaric hypoxia and exercise in rats (HAPE model). The breakthrough results for the use of solnatide for the treatment of High Altitude Pulmonary Oedema (HAPE) were recently published in the scientific journal Chest (November 2016: http://journal.publications.chestnet.org/article.aspx?articleid=2583274).

 

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APEPTICO 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.

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 top-line results in the treatment of primary graft dysfunction in patients following lung transplantation.

In lung transplantation (LuTX), a healthy lung from a deceased donor replaces the damaged lung of a patient to increase quality of life or even survival time of the recipient. Despite refinements in lung preservation and improvements in surgical techniques and perioperative care, primary graft dysfunction (PGD) remains a significant cause of early morbidity and mortality after lung transplantation. In addition to significant morbidity and mortality in the early postoperative period, PGD can also be associated with an increased risk of acute rejection that may lead to graft dysfunction in the long term. Currently, there is no effective pharmacotherapy available for treatment of PGD.

The proof-of-concept phase IIa clinical study was conducted at the Departments of Thoracic Surgery and Intensive Care Medicine of the Medical University of Vienna. The primary objective of this interventional, randomised, placebo-controlled study was to assess the clinical effect of orally inhaled AP301-peptide on treatment of PGD in patients after primary lung transplantation in comparison to placebo.

Results from this study showed that oral inhalation of AP301-peptide led to an early resolution of pulmonary oedema, pronounced improvement of gas exchange and normalisation of respiratory parameters, shortening of duration of mechanical ventilation and intensive care treatment, and earlier discharge of patients from hospital, when compared to placebo. On average, AP301-peptide treated patients were weaned from mechanical ventilation 1.5 days earlier, ICU treatment was terminated 3 days earlier and patients were discharged from the hospital up to 5 days earlier.

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APEPTICO 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

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).

Based on its discovery work on interactions of the pulmonary epithelial sodium ion channel (ENaC) and various pharmacodynamically active protein structures, APEPTICO has been encouraged by the European Medicines Agency (EMA, London) to apply for a Pathfinder Award of the Wellcome Trust. The Wellcome Trust is an internationally leading charitable foundation dedicated to achieving extraordinary improvements in health by supporting the brightest minds. The Pathfinder Scheme offers pilot funding for discrete projects from partnerships between academia and industry to catalyse innovative early-stage applied research and development projects in areas of unmet medical need.

APEPTICO's Pathfinder Award "Effect of a synthetic peptide on PHA type 1b causing mutations in the amiloride-sensitive epithelial sodium channel (ENaC)" addresses the orphan disease Pseudohypoaldosteronism type 1b (PHA type 1b), a life-threatening condition in which the sodium ion channel, ENaC, found in kidneys, colon, lungs, salivary and sweat glands has either reduced or no functionality.

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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, 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.

Oral inhalation of medicines by patients represents an alternative delivery route for therapeutic molecules in comparison to intravenous application. For treatment of various lung dysfunctions, small chemical molecules in combination with various carrier compounds are commonly used to acquire inhalable medicines used by patients with so-called dry powder inhalers (DPI). So far, inhalable medicine has been restricted to small molecules, while macromolecules such as proteins and peptides appeared unsuitable to form spherical powder particles with diameters of just a few microns.

By applying a sophisticated process that atomises APEPTICO's proprietary small protein ‘Solnatide' in a spray-drying process, APEPTICO in collaboration with Upperton Ltd. (Nottingham, United Kingdom) and Hovione Ltd. (Loures, Portugal) succeeded in the conversion of Solnatide into micrometer scale, spherically shaped, carrier-free dry powder particles that fulfil all the technical requirements for use with a dry powder inhaler. APEPTICO develops Solnatide for therapeutic treatment of pulmonary dysfunctions characterised by the presence of a life-threatening lung oedema and injury of the lung tissue. Liquid aerosol formulations of Solnatide have been successfully clinically tested in patients with pulmonary permeability oedema and Acute Respiratory Distress Syndrome and in patients with primary graft dysfunction following lung transplantation.

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APEPTICO granted Orphan Medicinal Product Designation by EMEA for lead product AP301

Vienna, Austria, 20th July, 2009 - 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”.

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APEPTICO GmbH erhält Preis anlässlich der Verleihung des “Venture Capital & Private Equity Award Österreichs“

Wien, Österreich, 9. Juni, 2009 -  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.

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APEPTICO GmbH closes seed financing round

Vienna, Austria, 29th May, 2009 - APEPTICO, a biotechnology company developing novel peptide-based drugs, announced completion of a seed financing round. The EUR 1Mio 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).

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Medical breakthrough for treatment of Acute Lung Injury

Vienna, Austria, 26th March, 2009 - 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.

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APEPTICO presents its lead product AP301 at the Annual Congress of the European Respiratory Society in Vienna, Austria

Vienna, Austria, 8th September, 2009 - 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.

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