Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Amira Pharmaceuticals has completed a Phase I clinical trial of an internally discovered oral drug candidate for the treatment of inflammatory diseases linked to the leukotriene pathway. Amira also announced the start of a Phase I trial for a second oral drug candidate that targets the same inflammatory response.
Subscribe to our email newsletter
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 leukotrienes (LT) production.
Results from the Phase I 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. Pharmacodynamic data demonstrated a robust and statistically significant reduction of LTB4 and LTE4 in a dose-dependent manner.
AM103 and AM803 are novel inhibitors of 5-lipoxygenase-activiting protein (FLAP) that have demonstrated potential to treat asthma and cardiovascular disease by preventing the synthesis of LT, which trigger inflammation.
Bob Baltera, chief executive officer of Amira, said: “Based on this very favorable profile, the excellent tolerability and the high levels of exposure obtained with oral dosing in Phase I studies, we are moving forward to conduct a Phase II study with AM103 in asthmatic patients. In addition, we have initiated a Phase I study with our second FLAP inhibitor, AM803, using a similar trial design to AM103.”