APEPTICO - Innovation in peptide drugs

APEPTICO 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’.

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'.

Primary graft dysfunction (PGD) refers to acute allograft dysfunction within the first 72 h following lung transplantation in the absence of identifiable secondary causes. PGD is characterized by poor oxygenation and low pulmonary compliance; it affects approx. 30% of all lung transplant recipients for whom it represents a significant cause of early morbidity and mortality. Currently, no satisfactory method of treatment exists.

This was the first time that a development compound has been granted orphan medicinal product designation for this life-threatening condition by the European Medicines Agency.

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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 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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Scientific results highlighted in an Editorial of the Americal Journal of Respiratory Critical Care

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".

In the most recent EDITORIAL in "American Journal of Respiratory Critical Care" (Am J Respir Crit Care Med Vol 190(6), pp 595-605, Sep 15, 2014; http://www.atsjournals.org/doi/abs/10.1164/rccm.201407-1364ED#.VBfyMha7ZbI) by Gary C. Sieck and Mark E. Wylam from the Mayo Clinic, Rochester, both the ground-braking scientific discoveries and the clinical-therapeutically potential of AP301 peptide have been highlighted.

In the EDITORIAL the authors summarise as follow "Previously, the lectin-like domain of TNF-alpha was shown to activate ENaC in type 2 alveolar epithelial cells (Ref. 1). Importantly, this effect has been mimicked by a small 17-amino acid circular peptide known as TNF inhibitory peptide (TIP; APEPTICO code "AP301"). A recent European study compared placebo treatment with TIP inhalation in patients with ALI/ARDS and found that TIP elicited earlier and more pronounced clearance of pulmonary edema (Ref. 2, Ref. 3). The molecular mechanism underlying TIP-induced ENaC activation remained uncertain until the study by Czikora and colleagues, published in the September 1, 2014, issue of the Journal (Ref. 4)."

The EDITORIAL makes explicate reference to APEPTICO's most recently completed phase IIa clinical study in patients with ARDS and pulmonary oedema. During the European Respiratory Society International Conference (Munich, 6-9 September 2014), Dr. Krenn from the Department of Intensive Care Medicine, Medical University of Vienna, reported key findings of the AP301-trial in mechanically ventilated patients with pulmonary permeability oedema.

The EDITORIAL concludes, "Taken together, these basic science results provide new physiological insight into the potential role of the lectin-like domain of TNF-a (AP301 peptide) and support the novel therapeutic use of AP301 aerosols in patients with ALI/ARDS and ischemia reperfusion lung injury."

In addition, Dr. Krenn's presentation of the AP301 clinical trial at the ERS International Conference was immediately reflected as "Top story of the week" in Pulmonary/Respiratory Medicine (http://dgnews.docguide.com/novel-peptide-activates-pulmonary-oedema-clearance-mechanically-ventilated-patients). MUNICH, Germany -- September 10, 2014: Jenny Power reported "Novel Peptide Activates Pulmonary Oedema Clearance in Mechanically Ventilated Patients. -- Acute lung injury (ALI) mediated by acute pulmonary permeability oedema can be reduced by a novel synthetic peptide that promotes pulmonary oedema clearance by decreasing extra-vascular lung water (EVLW) among mechanically ventilated patients in the intensive care unit (ICU)." (PDF copy attached).

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APEPTICO GmbH closes second financing round

Vienna, Austria, 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. 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).

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APEPTICO's lead molecule AP301 has been validated in the experimental lung transplantation model to prevent ischemia reperfusion injury

Vienna, Austria, 23rd February, 2010 - 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 the experimental lung transplantation model where intratracheal application of AP301 dramatically improved oxygenation after lung transplantation.

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APEPTICO granted Orphan Drug Designation by FDA for development compound AP301

Vienna, Austria, 10th February, 2010 - APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs, today announced that it has received Orphan Drug 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".

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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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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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