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news.The US Food and Drug Administration (FDA) has granted orphan drug status to Amira Pharmaceuticals' AM152 as a treatment for idiopathic pulmonary fibrosis (IPF).
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Amira Pharma is now concluding Phase 1 studies with AM152, a lysophosphatidic acid (LPA) receptor 1 antagonist.
Further, the company is planning to execute the Phase 2 trial by the end of 2011 or in early 2012.
Amira Pharma CEO Bob Baltera said this is an important development for Amira, and potentially patients suffering from IPF, as they continue to move this promising therapeutic candidate forward in development.
"Currently there are no FDA-approved therapies for IPF, and we look forward to better understanding the potential therapeutic benefit of an LPA1 antagonist in this disease area," Baltera said.