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news.Apeiron Biologics announced that GlaxoSmithKline (GSK), that has licensed Apeiron´s new investigational recombinant human Angiotensin Converting Enzyme 2 (rhACE2, name: GSK2586881, formerly APN01), has commenced a phase IIa study in patients suffering from Acute Lung Injury.
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The study being sponsored by GSK, will involve patients with a positive diagnosis of ALI and will be conducted throughout the US and Canada.
The efficacy of the enzyme was assessed in several preclinical animal models of ALI/ARDS.
A phase I study in healthy volunteers also investigated the safety, tolerability and pharmacology profile of rhACE2.
In January 2010, GSK acquired an exclusive license for the development and commercialization of GSK2586881 for EUR 230m, subject to reaching future development milestones in multiple indications.
Apeiron CEO Hans Loibner said the company is happy that their biologic APN01 is being tested by their 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," Loibner added.