Amira Pharmaceuticals Reports Status of Inflammatory Candidates

Amira Pharmaceuticals has completed its Phase I trial of AM103, the company’s oral drug candidate for inflammatory diseases linked to the leukotriene pathway. Amira also has started a Phase I trial for AM803, which targets the same inflammatory response.

The candidates are novel inhibitors of 5-lipoxygenase-activiting protein and have demonstrated the potential to treat asthma and cardiovascular disease by preventing the synthesis of leukotrienes.

The trial assessed the safety and tolerability of an escalating single dose of the compound and escalating multiple doses in healthy volunteers who received either AM103 or placebo for up to 11 days.

Results from the trial show AM103 is safe and well tolerated at doses up to 1,000 mg with no evidence of significant side effects, Amira said.

Bob Baltera, Amira’s CEO, said the results of the study indicate the drug should move into a Phase II study in asthmatic patients.

The Phase I study with AM803 will use a similar trial design to AM103.