Napo Pharmaceuticals, Jaguar Animal Health announce crofelemer data
Napo Pharmaceuticals and Jaguar Animal Health announced the results of a supplemental analysis of the long-term trial of crofelemer in patients with chronic HIV-related diarrhea. The analysis revealed a mean decrease of over 70% in diarrhea episodes versus baseline and over 50% of patients with complete resolution of their diarrhea. The results were reported at the 9th International AIDS Society Conference on HIV Science on Wednesday, July 26 in Paris, France. Mytesi is the only drug that has been specifically studied in and FDA-approved for use in managing diarrhea in people living with HIV. The safety and efficacy of crofelemer in reducing HIV-related diarrhea were assessed in the ADVENT trial. While the primary efficacy and safety results have previously been reported, this supplemental analysis was conducted to provide a more complete understanding of the long-term efficacy of crofelemer in patients with chronic HIV-related diarrhea. Prior to study entry, patients enrolled in the ADVENT trial had an average of 20 watery stools per week. Key results of this analysis showed: An average reduction of 73% in diarrhea episodes by week 24 of crofelemer treatment; More than 75% of patients had a clinically meaningful reduction in diarrhea, as measured by at least a 50% decrease in the number of episodes; More than 50% of patients had a complete resolution of their diarrhea by week 24 of crofelemer treatment; There was no significant difference between patients who were taking a protease inhibitor and those who were not or based upon the cause of the diarrhea.