Amira Pharmaceuticals Announces Initial Positive Phase 1 Clinical Data for AM461, A Back-Up to Amira's Lead DP2 Antagonist, AM211

Results Demonstrate Positive Proof of Mechanism

SAN DIEGO, Dec. 3 /PRNewswire/ -- 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.
 

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®. 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.

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

Web Site: http://www.amirapharm.com/
 

Posted: December 2009

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