Amira Pharmaceuticals, Inc. announced initial positive data from a phase I clinical study of AM152, the company’s oral selective antagonist of the LPA1 receptor. Completion of this study positions Amira to initiate a phase II a study in patients suffering from systemic sclerosis, a systemic fibrotic disease, by early 2012.

“The phase I clinical study in healthy volunteers demonstrated that AM152 is safe and well-tolerated at doses which are expected to provide a full range of receptor coverage in humans,” said Isabelle DeArmond, vice president, Clinical Development. “These results enable us to study AM152 at a wide range of doses in patients suffering from fibrotic diseases.”

Bob Baltera, chief executive officer, added, “Initiating a phase II a study in patients suffering from systemic sclerosis will be an important milestone for the team at Amira; we look forward to better understanding the potential therapeutic benefit of AM152.”

AM152 is a novel LPA1 receptor antagonist developed by the scientists at Amira. Preclinical data has demonstrated that antagonism of the LPA1 receptor inhibits fibrosis in several disease models. Much of these data has been previously presented and published by Amira scientists and colleagues. Amira Pharmaceuticals also recently announced that AM152 was granted Orphan Drug Status by the FDA for patients suffering from Idiopathic Pulmonary Fibrosis (IPF).

Amira Pharmaceuticals is a small molecule pharmaceutical company focused on the discovery and early development of new drugs to treat inflammatory and fibrotic diseases. Amira has a partnership with GlaxoSmithKline for the development of FLAP (5-lipoxygenase activating protein) inhibitors in respiratory and cardiovascular disease.