Promising New Drug To Reduce Risk of Myocardial Infraction and Stroke

SAN DIEGO, California, July 16-- Amira Pharmaceuticals, a small molecule pharmaceutical company focused on the discovery and development of compounds to treat inflammatory diseases, today announced initial, positive data from a Phase 1 clinical trial of AM103. The early, interim results demonstrate that a single dose of AM103 achieves highly significant inhibition of leukotriene synthesis, linked to a significant increase in the risk of myocardial infarction and stroke. AM103 binds to FLAP, inhibiting the synthesis of leukotrienes that cause inflammation. .

AM103 is an oral, next generation inhibitor of 5-lipoxygenase-activating protein (FLAP) that has demonstrated potential to treat asthma and cardiovascular disease (CVD) by preventing the synthesis of leukotrienes, biological compounds which lead to inflammation. The current placebo- controlled, double-blind Phase 1 study is designed to determine the safety and tolerability of an escalating single dose and escalating multiple doses of AM103 in healthy volunteers. The trial is also assessing the pharmacokinetic and pharmacodynamic properties of the compound, specifically its ability to inhibit leukotriene production.

"Our pre-clinical studies of AM103 demonstrated that a low dose is effective in several inflammatory models," said Peppi Prasit, PhD, chief scientific officer, Amira Pharmaceuticals. "Recent studies have shown that leukotrienes are implicated in atherosclerosis, suggesting that AM103 may have tremendous potential in cardiovascular indications in addition to the recognized respiratory indications."