APEPTICO - Innovation in peptide drugs

Meet APEPTICO

At the 14th Annual Biotech in Europe Forum, 30th September - 1st October 2014 • Congress Center Basel: The forum is recognised as the leading international stage for those interested in investing and partnering in the biotech and life science industry and is highly transactional. The Forum draws together an exciting cross-section of early-stage/pre-IPO, late-stage and public companies with leading investors, analysts, money managers and pharma licensing executives.

At BIO-Europe Spring (March 10th-12th, 2014): APEPTICO Forschung und Entwicklung GmbH announced that it will be participating at BIO-Europe Spring (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.

At BIO-Europe (November 4th-6th, 2013): APEPTICO Forschung und Entwicklung GmbH participates at the 19th Bio-Europe Conference held in Vienna, Austria. BIO-Europe is Europe's largest partnering conference, serving the global biotechnology industry.

At the BIO International Convention (June 18th - 21st, 2012): Apeptico Forschung und Entwicklung GmbH will attend the BIO International Convention (Boston). We will exhibit at booth 3265 (Austria Pavilion) and present the progress of AP301 clinical development.

At the Long Night of Research (April 27th, 2012):
APEPTICO Forschung und Entwicklung GmbH participates at the "Lange Nacht der Forschung" (Long night of research) in Vienna, Austria. The "Lange Nacht der Forschung" is dedicated to present innovation and innovative projects to the people of Austria. APEPTICO will present its peptide technology in the exhibition "The World of Innovation" of the Patent Office of Austria.

At the BIO-Europe (October 31st - November 2nd, 2011): APEPTICO Forschung und Entwicklung GmbH participates at the Bio-Europe in Duesseldorf, Germany. BIO-Europe is Europe's largest partnering conference, serving the global biotechnology industry.

At the 2011 ERS Annual Congress (September 24th-28nd, 2011): During the 2011 Annual Congress of the European Respiratory Society in Amsterdam, Apeptico Forschung und Entwicklung GmbH will present significant research results of its inhalation therapy for prevention and treatment of Oedematous Respiratory Failure to the scientific community.

At the Bio International Convention (June 27th - 30th, 2011): Apeptico Forschung und Entwicklung GmbH will attend the BIO International Convention (Washington DC). We will exhibit at booth 3137 (Austria Pavilion) and present latest finding of the AP301 clinical study during the Company Presentation event.

At the BIO-Europe (November 15th-17th, 2010): APEPTICO Forschung und Entwicklung GmbH takes part at the Bio-Europe in Munich, Germany. BIO-Europe is Europe's largest partnering conference, serving the global biotechnology industry.

At the 20th ERS Annual Congress (September 18th-22nd, 2010): During the 20th Annual Congres of the European Respiratory Socienty in Barcelona, Apeptico Forschung und Entwicklung GmbH will present its most recent study results of AP301 lead peptide in the tracheal inhalation model of Acute Lung Injury / Acute Respiratory Distress Syndrome.

At the BIO International Convention (May 2nd-5th, 2010): Apeptico Forschung und Entwicklung GmbH will attend the BIO International Convention (Chicago).

At the BioSquare (February 1st-2nd, 2010) and Bio-Europe Spring (March 8th-10th, 2010): Apeptico Forschung und Entwicklung GmbH will present the company and development products at the BioSquare (Geneva) and Bio-Europe Spring (Barcelona).

At the Bio-Europe (November 2nd-4th, 2009): APEPTICO Forschung und Entwicklung GmbH takes part at the Bio-Europe in Vienna, Austria. BIO-Europe is Europe's largest partnering conference, serving the global biotechnology industry.

At the Science4Life Messe (October 22nd, 2009): APEPTICO Forschung und Entwicklung GmbH will present its development compounds at the Science4Life Messe in Frankfurt, Germany.

At the CPhI (October 13th-15th, 2009): APEPTICO Forschung und Entwicklung GmbH will attend this year's CPhI in Madrid, Spain. The event covers more than 50,000 sq m of exhibition space, hosting over 1,400 exhibitors and is the market leader for the global pharmaceuticals ingredients industry.


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 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 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 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 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 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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Tel +43-664-1432919  |  Mail office@apeptico.com