Initial positive data from Amira Pharmaceuticals' Phase 1 clinical study of AM461 DP2 antagonist

Amira Pharmaceuticals, Inc. announced today initial positive data from a Phase 1 clinical study of AM461, the Company's second oral selective antagonist of the DP2 (also known as CRTH2) receptor.

The interim results demonstrate that a dose proportional pharmacodynamic (PD) effect can be achieved with AM461. Additionally, AM461 Phase 1 data to date demonstrates a good safety profile. AM461 is a back-up to Amira's lead DP2 antagonist, AM211, which has successfully completed Phase 1 clinical studies.

"The AM461 clinical data further strengthens our commitment to the DP2 receptor as a clinical target. Amira now has two structurally distinct, clinical-stage compounds targeting the receptor," said Isabelle DeArmond, Vice President, Clinical Development.

"Our approach to drug development is based upon bringing multiple structurally and metabolically distinct compounds forward in development. In addition to AM211 and AM461, we have additional novel DP2 antagonist molecules in reserve," said Bob Baltera, Chief Executive Officer.

While there are no DP2 selective antagonists approved for therapeutic use, there is a strong scientific rationale for this target to be a novel treatment of asthma, chronic obstructive pulmonary disease (COPD) and allergic rhinitis. A DP2 antagonist has the potential to be disease modifying in these aforementioned conditions. DP2 is also known as CRTH2, or chemoattractant receptor-homologous molecule expressed in Th2 lymphocytes. DP2 is a high affinity receptor for the prostaglandin D2 and in humans is implicated in Th2-dependent allergic inflammation.

SOURCE Amira Pharmaceuticals, Inc.