Forest Laboratories and Glenmark Pharmaceuticals, a wholly owned subsidiary of Glenmark Pharmaceuticals India (GPL) today announced top-line results from a phase IIb dose range-finding study of oglemilast in patients with Chronic Obstructive Pulmonary Disease (COPD).
Once-daily treatment with oglemilast did not show a statistically meaningful increase from baseline compared to placebo in the primary endpoint trough FEV1. Oglemilast was well tolerated at all doses studied.
A twelve-week randomized, double-blind, placebo-controlled, multi-center phase IIb study that evaluated the efficacy and safety of once-daily oglemilast at doses of 200mcg, 400mcg and 800mcg in patients with moderate to very severe COPD.
Howard Solomon, chairman and chief executive officer of Forest Laboratories, said: “Oglemilast is an orally administered PDE 4 inhibitor, which we believe to be an important and novel therapeutic target for COPD. We are, of course, disappointed that oglemilast has not been successful in this study. Oglemilast is still being studied for the treatment of asthma, with results expected during the first calendar quarter of 2010. We are considering together with Glenmark what further action would be useful or appropriate.”