Glenmark Pharmaceuticals SA [GPSA], the wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd., announced that its lead molecule for asthma/COPD, Oglemilast [GRC 3886], has entered Phase II. The Phase II trials are being conducted in the US by Glenmark's development partner for Oglemilast in North America, Forest Laboratories, Inc.
According to the company release, two early Phase II studies are currently underway. One study is exploring the effect of Oglemilast in mild asthmatic patients facing an antigen challenge. The second study is evaluating efficacy of Oglemilast in exercised induced asthma. Additional Phase II studies in asthma and COPD patients are planned; the first study is expected to commence by mid 2006. Based on pharmacokinetics and safety profile seen in Phase I, the Phase II studies will utilize a once-daily-dosing regimen.
Glenn Saldanha, Managing Director and CEO, Glenmark Pharmaceuticals Ltd. stated, "We are on-track with our studies for Oglemilast. We expect to complete Phase II by second half of 2007."
Pharmacology results revealed that in in-vitro studies, Oglemilast is a highly selective PDE-4 inhibitor, it has excellent cellular permeability, and it inhibits LPS induced TNF-alpha in Human Whole Blood. In animal models of pulmonary inflammation, Oglemilast was found to be very active on LPS induced TNF-alpha release and inhibition of neutrophils and eosinophil influx. Additionally, results of Phase I studies revealed that Oglemilast was well tolerated. At the doses explored, Oglemilast was not emetic and did not appear to have cardio-vascular side effects. Taken in totality, these results support the further development of Oglemilast in asthma and COPD, stated the release.