Forest Laboratories and Glenmark Pharmaceuticals announced top-line results from a Phase 2b dose range-finding study of oglemilast in patients with Chronic Obstructive Pulmonary Disease (COPD). This twelve-week randomized, double-blind, placebo-controlled, multi-center study evaluated the efficacy and safety of once-daily oglemilast at doses of 200mcg, 400mcg and 800mcg in patients with moderate to very severe COPD. The primary endpoint was defined as change from baseline in pre-bronchodilator (morning/trough) FEV1 at Week 12. Once-daily treatment with oglemilast did not show a statistically meaningful increase from baseline compared to placebo in the primary endpoint trough FEV1, a measure of pulmonary function that is decreased in patients with COPD.
Oglemilast is a potent and selective inhibitor of phosphodiesterase 4 (PDE4) in development for the treatment of COPD and asthma.
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