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.
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