GSK initiates rhACE2 phase IIa study for Acute Lung Injury

APEIRON Biologics AG (Apeiron) announced today that GlaxoSmithKline (GSK), exclusive, worldwide licensee for Apeiron's new investigational recombinant human Angiotensin Converting Enzyme 2 (rhACE2, name: GSK2586881, formerly APN01), has initiated a phase IIa study in patients suffering from Acute Lung Injury.

Apeiron today announced the initiation of a phase IIa clinical study of rhACE2, in patients with Acute Lung Injury (ALI). The study, of which Apeiron's licensee GSK is sponsor, will include subjects with a positive diagnosis of ALI, and will be conducted in the intensive care units of multiple hospitals throughout the United States and Canada.

ALI is an acute, severe injury to the lungs associated with a variety of underlying conditions, such as sepsis, aspiration of acidic gastric contents, trauma, postoperative complications, acute pancreatitis, and pneumonia. According to recent studies, it annually affects hundreds of thousands of individuals worldwide. There are currently no pharmaceutical therapies available to treat this life-threatening condition. The most severe form of ALI, the Acute Respiratory Distress Syndrome (ARDS) has a mortality rate of over 20-40%. The efficacy of GSK2586881 has been tested in several preclinical animal models of ALI/ARDS. A phase I study in healthy volunteers also investigated the safety, tolerability and pharmacology profile of this investigational medicine.  In January 2010, GSK acquired an exclusive, worldwide license to further develop and commercialize GSK2586881 in a deal worth up to EUR 230 Mio, subject to reaching future development milestones in multiple indications.

Hans Loibner, CEO of Apeiron stated: "We are excited to see our innovative biologic APN01, after only 6 years in development, now being tested by our licensee GSK in a multicentric phase II study in ALI patients. The study is designed to provide important information regarding the safety and pharmacologic profile of this recombinant enzyme in this severely diseased patient population, as well as first insights into its clinical efficacy. This event is an important milestone for our company and validates our efforts to clinically advance novel therapies for severe conditions where there is significant unmet medical need."