Amira Pharmaceuticals Announces Initial Positive Phase 1 Clinical Data for AM211, a Novel Product Candidate for the Treatment of Respiratory Diseases

- Results Demonstrate Positive Proof of Mechanism

SAN DIEGO, June 30/PRNewswire/ -- Amira Pharmaceuticals, Inc. announced today initial positive data from a Phase 1 clinical study of AM211, the company's oral selective antagonist of the DP2 (also known as CRTH2) receptor.

The interim results demonstrate that a sustained pharmacodynamic (PD) effect can be achieved with a single dose of AM211. The pharmacokinetic profile indicates safety multiples as compared to exposures observed in safety species. 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.

"The AM211 clinical PD data confirms what we previously observed in pre-clinical models," said Isabelle DeArmond, M.D., Vice President, Clinical Development. "While a great deal of clinical work remains on this program, we are particularly excited since we believe DP2 antagonism would be a novel therapeutic approach to various respiratory diseases."

Bob Baltera, Chief Executive Officer, added, "Once again the Amira team demonstrates our ability to quickly, efficiently and accurately translate scientific efforts into meaningful therapeutic candidates. The fact that we now have clinical data only 25 months after we initiated scientific efforts on this target in our laboratories is a source of pride for the entire Amira team."

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.

    
    Media Contact
    Ian Stone
    Russo Partners
    Tel: +1-619-528-2220
    ian.stone@russopartnersllc.com

Source: Amira Pharmaceuticals, Inc.

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

Posted: July 2009

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