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news.Trine Pharmaceuticals has initiated enrollment in a phase IIb study evaluating the efficacy and safety of Napo Pharmaceutical's lead product candidate, crofelemer, for the treatment of female patients suffering from irritable bowel syndrome.
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Crofelemer is a natural product sustainably harvested from the rain forest. It is extracted from the medicinal plant, Croton lechleri.
Trine has worldwide development and commercialization rights to crofelemer for the IBS indication. Within thirty days following the initiation of this study, Trine will pay Napo a milestone payment of $1 million.
This study is expected to enroll approximately 240 women in the US who have diarrhea-predominant IBS. The primary endpoint of this study will be the improvement of abdominal pain associated with the condition.
“With the activity observed in the phase IIa study and the risk mitigation provided by leveraging an extensive safety database of over 1,500 patients involved in clinical testing of crofelemer across four indications, we have high expectations for this new trial,” commented Lisa Conte, CEO of Napo Pharmaceuticals.