Amira Pharmaceuticals Announces Favorable Phase 1 Clinical Trial Results for Lead Product Candidate AM103 and Initiates Clinical Studies for the 2nd Entry Molecule for the Treatment of Respiratory and Cardiovascul...( SAN DIEGO Nov. 1 /- Amira Pharmac...),Health

SAN DIEGO, Nov. 1 /PRNewswire/ -- Amira Pharmaceuticals, Inc. announced completion of the company's Phase 1 clinical trial of AM103, Amira's internally discovered oral drug candidate for the treatment of inflammatory diseases linked to the leukotriene pathway. Amira also announced the start of a Phase 1 trial for AM803, a second oral drug candidate that targets the same inflammatory response.

AM103 and AM803 are novel inhibitors of 5-lipoxygenase-activiting protein (FLAP) that have demonstrated potential to treat asthma and cardiovascular disease (CVD) by preventing the synthesis of leukotrienes (LT), which trigger inflammation. The recently completed AM103 trial was designed to assess the safety and tolerability of an escalating single dose of the compound and escalating multiple doses in healthy volunteers who received AM103 or placebo for up to 11 days. The trial also assessed the pharmacodynamic properties of AM103, specifically its ability to inhibit LT production.

Results from the Phase 1 trial show that AM103 is safe and well-tolerated at doses up to 1,000 mg per day with no evidence of significant side effects. The systemic exposure of AM103 increased linearly from 50 mg to 1,000 mg.

Pharmacodynamic data demonstrated a robust and statistically significant reduction of LTB4 and LTE4 in a dose-dependent manner. "The results from this trial meet and even exceed our expectations for safety, and provide pharmacodynamic evidence consistent with this mechanism of action," said Peppi Prasit, Amira's chief scientific officer. "The half-life of up to 10 hours also gives us the opportunity to evaluate once-daily dosing in a Phase 2 trial, which we expect to start in 2008."

"Based on this very favorable profile, the excellent tolerability and the high levels of exposure obtained with oral dosing in Phase 1 studies, we are moving forward to conduct a Phase 2 study with AM103 in asthmatic patients," said Bob Baltera, Amira's chief executive
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