Yesterday, Forest Laboratories (FRX) announced disappointing results from the mid-stage clinical trials of oglemilast, meant for chronic obstructive pulmonary disease (COPD) that usually affects smokers. The drug was being developed with Glenmark Pharmaceuticals S.A. (Switzerland), a wholly owned unit of India-based Glenmark Pharmaceuticals. The phase IIb trial was conducted to determine the proper dosage for the drug.
The 12-week trial was conducted on 428 patients aged 40 years or more and who had been smokers for about ten years. Oglemilast failed to show any improvement compared to a placebo during the study which evaluated a once-daily dosage of the drug in three dosage strengths (200 mcg, 400 mcg and 800 mcg). All 428 patients were randomized to receive one of the three doses of oglemilast (n=320) or placebo (n=108) and were assessed during the eighth visit.
The primary endpoint was defined as change from baseline in pre-bronchodilator (morning/trough) FEV1 (a measure of pulmonary function that is lower in COPD patients) at Week 12. The drug was well tolerated at all three dosage levels. COPD refers to obstruction of airways caused by chronic bronchitis. The disease affects about 14 million people in the U.S. and is the fourth most common cause for death.
Had the drug been approved, it would enter a highly competitive COPD market. Despite this setback, Forest announced that the drug would be studied for the treatment of asthma, with results expected early next year.
The lucrative COPD market recently led Forest into a deal with Switzerland-based Nycomed for US marketing rights of Daxas, an experimental drug for lung disease. Forest has another pipeline candidate aclidinium (in phase III), a multi-dose, dry-powder inhaler for COPD.
While aclidinium met the primary endpoint, its effect on FEV-1 was lower than expected. Overall, the efficacy data looked to be considerably inferior to Pfizer’s (PFE) Spiriva and thus brings into question the marketability of the drug at the 200mcg/day dose.
Forest has decided to pursue additional testing at higher and/or more frequent doses. This additional trial should start in the second half of the calendar year and offer data in the first half of calendar 2010. We believe the additional trials will push back the New Drug Application (NDA) filing to 2011.
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