31st August, 2012, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs for the treatment of life threatening lung diseases today announced that it will present most recent clinical research results of its inhalation therapy for prevention and treatment of Oedematous Respiratory Failure at the 2012 Annual Congress of the European Respiratory Society.
At the 2012 Annual Congress of the European Respiratory Society (ERS) in Vienna (Austria, September 1st to 5th, 2012), APEPTICO will present both phase I clinical and significant scientific research results of its inhalation therapy for prevention and treatment of Oedematous Respiratory Failure to the scientific community. The scientific advisory board of the ERS has appointed in total three contributions of APEPTICO to be presented at this major event.
In his presentation “Dose escalation study in healthy male subjects to investigate safety, tolerability and systemic exposure of orally inhaled single-doses of AP301” Dr. H. Pietschmann will summarise essential results of the outcome of the phase I clinical study of APEPTICO’s lead compound AP301. In this clinical study, the safety, tolerability and pharmacokinetic profile of AP301 was evaluated in a double-blind, randomized, placebo-controlled, parallel group study at the General Hospital in Vienna. Study participants received escalating doses of aerosolized AP301 in 6 dose groups between 0.07 mg/kg to 2 mg/kg AP301 per inhalation. This phase I trial demonstrated that orally inhaled AP301 was safe and well-tolerated by all study subjects. Dr. H. Fischer will give an overview of the pharmaceutical development work for the inhalation medicine in his presentation entitled “Pharmaceutical development of a liquid formulation for pulmonary application of a peptide”. Dr. S. Tzotzos will concentrate on the molecular target and mode of action of APEPTICO’s AP301 peptide in “ENaC activating effect of AP301 in type II alveolar cells isolated from dog, pig and rat lungs”.
APEPTICO’s lead peptide AP301 is currently subject to a Phase IIa clinical study in the Vienna General Hospital.
The ERS Congress is the largest international conference specialising in pulmonary medicine. It provides a unique forum where scientists and medical professionals from around the world have the opportunity to meet and exchange ideas and information in the field of respiratory medicine. The scientific programme of the ERS Congress aims to provide a perfect balance between clinical education and the latest scientific developments. The ERS Congress highlights key issues in the diagnosis, management and treatment of respiratory diseases, giving clinicians and research scientists the opportunity to report the latest findings in basic, clinical and population research.
Dr. Bernhard Fischer, CEO of APEPTICO commented: “I am pleased that the scientific organising committee of the ERS Annual Congress is giving us the opportunity to present the progress of our clinical drug development programme - the development of new medicines for prevention and treatment of Oedematous Respiratory Failure. Today no specific drug treatment exists for patients suffering from hyper-permeability-caused lung oedema.”
About APEPTICO GmbH
APEPTICO is a privately-held biotechnology company based in Austria, developing peptide-based products targeting chronic and life-threatening diseases. The peptide molecules correspond to validated, pharmacodynamic active structures and domains of well-known proteins and biopharmaceuticals. By concentrating on synthetically produced protein structures APEPTICO avoids general risks associated with gene- and cell-technologies. APEPTICO’s makes use of its technology platforms PEPBASETM and PEPSCREENTM to significantly reduce cost and to shorten time to market.
About the AP301 peptide family
AP301 and derived peptides are synthetic molecules whose structures are based on the lectin-like domain of human Tumour Necrosis Factor alpha. AP301 peptides are water soluble and can be administered into the lung by oral inhalation. Formulated AP301 is easily nebulised and the resulting aerosol is composed of peptide/water droplets of diameter 4 μm or less. AP301 and derived peptides are designed for activation of the pulmonary epithelial sodium channel (ENaC). Activation of ENaC by AP301 peptides results an accelerated oedema clearance in the airspace. Comprehensive research and development conducted by APEPTICO has demonstrated that AP301 peptides are effective in animal models of pulmonary permeability oedema, pneumonia, influenza virus lung infection, Acute Lung Injury / Acute Respiratory Distress Syndrome and lung transplantation. AP301 has received Orphan Drug Designation by the EMA and by the FDA for various indications. Currently, AP301 is subject to a Phase IIa clinical study for the treatment of patients suffering from life-threatening oedematous respiratory failure.
About Oedematous Respiratory Failure
Respiratory failure occurs when the respiratory system fails in oxygenation and/or carbon dioxide elimination. Oedematous Respiratory Failure is caused by a massive and life-threatening pulmonary oedema. Pulmonary oedema occurs when fluid leaks from the pulmonary capillary network into the lung interstitium and alveoli. There are many possible causes of lung oedema, such as inhaling high concentrations of smoke, toxins, or oxygen; severe burns; blood infections; lung infections; or trauma to other parts of the body. Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) are catastrophic forms of lung oedema.
Lungs contain alveoli, which are tiny air sacs where the oxygen is passed into the blood. During lung oedema, blood and fluid begin to leak into the alveoli. When this happens, oxygen cannot enter the alveoli, which means oxygen no longer passes into the blood. Because the lungs are inflamed and filled with fluid, the patient finds it increasingly difficult to breathe. The mortality rate of patients with pulmonary oedema in ALI/ARDS is 30% to 60% within 2 to 4 weeks.
Currently, no specific drug treatment exists for patients suffering from hyper-permeability-caused lung oedema.
APEPTICO presents clinical results of its inhalation therapy for prevention of Oedematous Respiratory Failure
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