Amira Pharmaceuticals Submits IND for Second DP2 Antagonist, AM461

SAN DIEGO -

Amira Pharmaceuticals, Inc. announced today the submission of an Investigational New Drug application (IND) of AM461, its internally-discovered, oral drug candidate for the treatment and control of inflammatory and allergic disease linked to the arachidonic acid pathway, to the U.S. Food and Drug Administration.

AM461 is an oral, selective antagonist of the receptor DP2, which recent studies have shown to be a potential target for the treatment of asthma, chronic obstructive pulmonary disease (COPD) and allergic rhinitis. The submission of the AM461 IND follows closely on the heels of Amira’s lead DP2 antagonist, AM211, which is currently in Phase I human testing.

“Taking two DP2 candidates into clinical trials within four months of each other demonstrates our conviction to the target as well as the depth of our DP2 program,” said Peppi Prasit, Chief Scientific Officer. “AM461 is structurally and metabolically distinct from AM211.”

DP2 is also known as CRTH2, or chemoattractant receptor-homologous molecule expressed on Th2 lymphocytes. DP2 is a high affinity receptor for the prostaglandin D2 and, in humans, is implicated in Th2-dependent allergic inflammation.

About Amira

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(R). 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.

Ian Stone of Russo Partners, +1-619-528-2220, ian.stone at russopartnersllc.com, for Amira Pharmaceuticals, Inc.