Amira initiates AM152 Phase 1 clinical study for fibrotic diseases

Amira Pharmaceuticals, Inc. announced today that it has initiated a Phase 1 clinical study with AM152, a novel LPA1 antagonist, in normal, healthy subjects.

"We are excited to begin our journey exploring the therapeutic value of AM152, a potentially novel anti-fibrotic agent.  Our first step is to understand the safety, pharmacodynamic (PD) and pharmacokinetic (PK) profile of this compound in normal healthy subjects," said Isabelle DeArmond, Vice President, Clinical Development.  "We expect to have these studies completed by the middle of next year, and assuming positive results, we could then begin to study the therapeutic utility of AM152 in patients."

"The Amira team is very proud and excited by this important milestone," said Bob Baltera, Chief Executive Officer. "Currently, there are no FDA-approved therapies for fibrotic disease, and we look forward to better understanding the potential therapeutic benefit of an LPA1 antagonist in this area of medicine."

While there are no LPA1 selective antagonists approved for therapeutic use, there is a strong scientific rationale for this as a target for novel treatment in various fibrotic diseases including scleroderma and idiopathic pulmonary fibrosis.