APEPTICO - Innovation in peptide drugs

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 announces breakthrough results in scientific understanding of alveolar liquid clearance regulation by the pulmonary epithelial sodium channel (ENaC)

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).

Alveolar liquid clearance is regulated by Na+ uptake through the apically expressed epithelial sodium channel (ENaC) and the basolaterally localised Na+-K+-ATPase in type II alveolar epithelial cells. Dysfunction of these Na+ transporters during pulmonary inflammation and bacterial infection can contribute to formation of life-threatening pulmonary permeability oedema.

Using a combined biochemical, electrophysiological and molecular biological approach in vitro and by performing in vivo studies in transgenic mice, Dr. Lucas' team from the Medical College of Georgia, Georgia Regents University, in collaboration with APEPTICO and researchers from the Institute of Pharmacology and Toxicology of Vienna University and from Emory University, demonstrated that the "TIP-peptide", which mimics the lectin-like (TIP) domain of TNF, directly activates ENaC, but not the Na+-K+-ATPase, upon binding to the carboxy-terminal domain of the ion channel's alpha subunit. Binding of the "TIP-peptide" to ENaC increases the open probability of the channel and preserves ENaC alpha protein expression in the presence of bacterial toxins, by means of blunting the protein kinase C alpha pathway. Transgenic mice lacking the TNF-derived lectin-like domain are more prone to develop oedema in the presence of bacterial toxins than wild type mice. All data have been published in the American Journal of Respiratory and Critical Care Medicine of 16th July, 2014.

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APEPTICO announces a licensing agreement for PEPBASE(TM) with Chem Tech Research Incorporation (C-TRI)

Vienna, Austria, 23rd October, 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), according to which 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 database updates.

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APEPTICO initiates phase II clinical trial with AP301 in patients with primary graft dysfunction following lung transplantation

Vienna, Austria, 17th April, 2013 -  APEPTICO, a privately-held biotechnology company developing peptide drugs based  on  its  PEPBASE™ 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. 

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APEPTICO announces top-line results in phase IIa clinical study of AP301 in treatment of pulmonary permeability oedema in mechanically ventilated patients

Vienna, Austria, 9th April, 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.

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APEPTICO accelerates its clinical development programme with a research grant from the Austrian Research Promotion Agency (FFG)

Vienna, Austria, 8th July, 2013 - APEPTICO, a privately-held biotechnology company developing peptide drugs based on its PEPBASE™ 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.

 

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APEPTICO granted Orphan Drug Designation by EMA and FDA for development compound AP301 for treatment of high altitude pulmonary oedema

Vienna, Austria, 18th January, 2013 - 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 Orphan Product Development (Food and Drug Administration, USA) for the clinical indication “treatment of High Altitude Pulmonary Oedema”.

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APEPTICO announces successful completion of Phase I trial with AP301 in oedematous respiratory failure

Vienna, Austria, 25th October, 2011 - APEPTICO GmbH, a biotechnology company developing peptide drugs based on its PEPBASE™ 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.

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APEPTICO initiates phase II trial with AP301 in patients with pulmonary oedema

Vienna, Austria, 29th June, 2012 - APEPTICO, a privately-held biotechnology company developing peptide drugs based on its PEPBASE™ 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.

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APEPTICO completes a EUR 3.4 million financing round

Vienna, Austria, 16th May, 2012 - 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).

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The 2010 Annual Congress of the European Respiratory Society has been a major success for APEPTICO

18th-22nd September, 2010 - APEPTICO represented at the 2010 Annual Congress of the European Respiratory Society held in Barcelona, Spain. The beneficial pharmacodynamic effects of APEPTICO's development compound AP301, also known as the "TIP peptide", were the subject of three presentations at the congress.

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APEPTICO's lead molecule AP301 has been validated in the porcine model of lung injury by inhalation of the peptide-aerosol

Vienna, Austria, 1st July, 2010 - APEPTICO Forschung und Entwicklung GmbH today announced that it has validated its lead molecule AP301 in the porcine model of lung injury by inhalation of the peptide-aerosol. In a poricine model of acute lung injury, APEPTICO's TIP-peptide AP301 was appplied vs. a control nebulisation of water for injection (WFI) under comparable ventilator settings and haemodynamic conditions. A sustained improvement of the lung function was recorded following AP301 nebulisation according to the parameters oxygenation index, extravascular lung water and pulmonary shunt fraction.


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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