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news.Napo Pharmaceuticals has reported that its licensee, Glenmark Pharmaceuticals has initiated a Phase II clinical trial for crofelemer for the indication of acute infectious diarrhea at two sites in India. This placebo-controlled crofelemer trial is expected to conclude in six months.
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Glenmark licensed crofelemer for the indications of acute infectious diarrhea, chronic diarrhea in persons living with HIV/AIDS and pediatric diarrhea in over 140 emerging economies and developing countries. Once these indications are approved in Glenmark’s territories, Glenmark will pay ascending royalties to Napo on sales of crofelemer for these indications.
Glenmark is the manufacturer of crofelemer API (active pharmaceutical ingredient) for Napo’s current Phase III trial for crofelemer for chronic diarrhea in persons living with HIV/AIDS, which is being conducted at sites in the US under a special protocol assessment agreement with the FDA.
Lisa Conte, CEO of Napo, said: “Including Glenmark’s current trial, we are expecting clinical results from four trials of crofelemer around the end of first quarter of 2008, including the interim results from the Phase III CRO-HIV trial and look forward to filing a NDA for this fast tracked indication in third quarter of 2008.”