APEPTICO Initiates Phase II Trial with AP301 in Patients with Pulmonary Oedema

Vienna, Austria, June 29, 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.

AP301 is the first compound against respiratory failure caused by pulmonary oedema that activates lung oedema reabsorption and thus differs from the currently used anti-inflammatory treatment that often fails in patients with acute lung injury. The synthetic peptide AP301 activates alveolar liquid clearance (ALC) and prevents hyper-permeability in both endothelial and epithelial lung tissue. AP301 also prevents ischaemia reperfusion injury in the lower respiratory tract following lung transplantation.

The interventional, randomized, double-blind, placebo-controlled, parallel-group “proof of concept” study is conducted in Austria. Intensive care patients will receive doses of AP301 or matching placebo converted into an aerosol by state-of-the-art nebuliser technology over a period up to 7 days.

"We are very pleased that both the Ethics Committee and the Competent Authority approved our study only a few weeks after completion of the phase I clinical trial” said Bernhard Fischer, CEO of APEPTICO. “Treatment of oedematous respiratory failure represents an unmet medical need as no specific therapy or medicinal product has been approved so far for the prevention and treatment pulmonary oedema caused by hyper-permeability.”

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