Napo reports successful Phase II results of crofelemer

The primary endpoints of the trial were stool weight, duration of diarrhea, stool frequency and stool consistency; additional endpoints followed include degree of patient dehydration and reduction in gastrointestinal index score. The conclusions from the study were that treatment with crofelemer was well tolerated and resulted in statistically significant improvements in all the primary endpoints and statistically significant reduction in the additional endpoints as well. Overall clinical success was achieved in 79.1% of the evaluable patients receiving crofelemer compared to 28.2% of the evaluable patients receiving placebo.

In conclusion, adult Indian patients with infectious diarrhea treated with crofelemer showed a faster recovery with the first dose itself as observed by the reduction in stool weight, stool frequency and passage of formed stools. Crofelemer was well tolerated and most adverse events were mild to moderate in severity and not different from the placebo group.

Lisa Conte, CEO of Napo, said: “Napo is extremely pleased to see the achievement of statistical significance in this trial and that once again, crofelemer’s safety profile has been confirmed. The success of this study is a very important step for Glenmark in its goal to develop crofelemer for CRO-ID (crofelemer for the treatment of acute adult infectious diarrhea) in its territories.”