August 1, 2017

Data Shows Dramatic Reduction in Chronic Diarrhea Episodes with Mytesi

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Napo Pharmaceuticals, Inc., a human health company developing and commercializing novel gastrointestinal prescription products from plants used traditionally in rainforest areas, and Jaguar Animal Health, Inc., announced the results of a supplemental analysis of the long-term trial of crofelemer (Mytesi�) in patients with chronic HIV-related diarrhea.

The analysis revealed a mean decrease of over 70 percent in diarrhea episodes versus baseline and over 50 percent of patients with complete resolution of their diarrhea. The results were reported at the 9th International AIDS Society (IAS) Conference on HIV Science on Wednesday, July 26, 2017 in Paris, France.

Mytesi (crofelemer) 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.

"Mytesi achieves much greater reductions in HIV-related diarrhea than was apparent in the ADVENT primary responder analysis," commented Dr. Rodger D. MacArthur, Medical College of Georgia, Augusta, GA. "Most patients saw meaningful reductions in diarrhea, with more than 75 percent experiencing at least a 50 percent reduction and more than half of patients experiencing complete resolution of diarrhea at week 24. I think it is important to note that results were consistent regardless of the use of a protease inhibitor or the cause of diarrhea."

Prior to study entry, patients enrolled in the ADVENT trial had an average of 20 watery stools per week (approximately three per day). Key results of this analysis showed:

  • An average reduction of 73 percent in diarrhea episodes by week 24 of crofelemer treatment;
  • More than 75 percent of patients had a clinically meaningful reduction in diarrhea, as measured by at least a 50 percent decrease in the number of episodes;
  • More than 50 percent 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.

    "With an estimated 20 percent of the more than 36 million people currently living with HIV suffering from diarrhea, there are more than seven million patients worldwide who may benefit from the reduction in diarrhea that can be achieved with Mytesi therapy," said Lisa Conte, Jaguar's president and CEO and Napo's interim CEO.

    The poster for this data presentation is available at: http://mytesi.com/clinical-results.html

    Launched by Napo Pharmaceuticals in October 2016, Mytesi is the only antidiarrheal studied in and U.S. FDA-approved for the symptomatic relief of noninfectious diarrhea in adults living with HIV/AIDS on antiretroviral therapy (ART). Mytesi is a prescription treatment for diarrhea that works differently, by acting locally in the GI tract to normalize the flow of water. Mytesi does not have any clinically relevant drug-drug interactions and has side effects that are similar to placebo.

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