, Sept. 27
/PRNewswire-FirstCall/ -- Amira Pharmaceuticals, Inc. announced today that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for AM152, a novel LPA1 antagonist. If accepted, the IND will enable Amira to begin Phase 1 safety studies with the compound in healthy subjects.
"We believe the pre-clinical data obtained to date for AM152 demonstrate characteristics which warrant further studies in humans to determine its potential utility in various fibrotic diseases," said Isabelle DeArmond, Vice President, Clinical Development. "The safety and pharmacokinetic data obtained from Phase 1 studies are an important first step in the clinical investigation of this program."
Added Bob Baltera, Chief Executive Officer, "We are extremely excited to reach this point with our LPA1 program. There have recently been numerous papers published describing the novel biology of the LPA1 receptor and how it relates to abnormal fibrotic processes. We have worked hard to develop this program and look forward to learning more about this potential therapeutic candidate in a clinical setting."
While there are no LPA1 selective antagonists approved for therapeutic use, there is a strong scientific rationale for this target to be a novel treatment in various fibrotic diseases, including scleroderma and idiopathic pulmonary fibrosis.
Founded in 2005 and headquartered in San Diego, Amira Pharmaceuticals is a small molecule pharmaceutical company focused on the discovery and early development of new drugs to treat inflammatory disease. Our discovery team is building on unparalleled insights into bioactive lipid pathways and complex signaling processes controlling many conditions including asthma, chronic obstructive pulmonary disease, cardiovascular and fibrotic diseases. Amira has a partnership with GlaxoSmithKline for the development of FLAP (5-lipoxygenase-activating protein) inhibitors in respiratory and cardiovascular disease.
Amira combines the rigor of a big pharmaceutical company with the ingenuity and energy of a small company, creating an environment for efficient development of novel compounds and effective pre-clinical and clinical program decisions. Its scientific founders have successfully worked together for more than a decade and were pivotal in the discovery of a number of inflammatory drugs, including Singulair®. The drug hunters at Amira are now actively leveraging their history of success to create high-value compounds for the future. For more information, visit www.amirapharm.com.
SOURCE Amira Pharmaceuticals, Inc.