SAN FRANCISCO--(BUSINESS WIRE)--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. (NASDAQ: JAGX) (Jaguar), announced today 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 use of a protease inhibitor or the cause of the 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.
Mytesi® (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi® is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi®. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
More information and complete Prescribing Information are available at Mytesi.com. Crofelemer, the active ingredient in Mytesi®, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
As announced March 31, 2017, Napo and Jaguar Animal Health, Inc. have entered a definitive merger agreement. The proposed merger of Jaguar and Napo remains subject to customary conditions to closing. Upon the consummation of the merger, Jaguar’s name will be changed to Jaguar Health, Inc., and Napo will operate as a wholly-owned subsidiary of Jaguar, focused on human health. Jaguar and Napo are holding their respective stockholder meetings to approve the merger on July 27, 2017.
About Napo Pharmaceuticals, Inc.
San Francisco-based Napo Pharmaceuticals, Inc. focuses on the development and commercialization of proprietary gastrointestinal pharmaceuticals for the global marketplace from sustainably derived plants used traditionally in rainforest areas.
For more information, please visit www.napopharma.com.
About Jaguar Animal Health, Inc.
Jaguar Animal Health, Inc. is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses. Canalevia™ is Jaguar’s lead prescription drug product candidate, intended for the treatment of various forms of diarrhea in dogs. Equilevia™ (formerly referred to as SB-300) is Jaguar’s prescription drug product candidate for the treatment of gastrointestinal ulcers in horses. Canalevia™ and Equilevia™ contain ingredients isolated and purified from the Croton lechleri tree, which is sustainably harvested. Neonorm™ Calf and Neonorm™ Foal are the Company’s lead non-prescription products. Neonorm™ is a standardized botanical extract derived from the Croton lechleri tree. Canalevia™ and Neonorm™ are distinct products that act at the same last step in a physiological pathway generally present in mammals. Jaguar has nine active investigational new animal drug applications, or INADs, filed with the FDA and intends to develop species-specific formulations of Neonorm™ in six additional target species, formulations of Equilevia™ in horses, and Canalevia™ for cats and dogs.
For more information about Jaguar, please visit www.jaguaranimalhealth.com.
Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the proposed merger between Jaguar and Napo, Jaguar’s intention to develop species-specific formulations of Neonorm™ in additional target species, and the Company’s plan to develop formulations of Canalevia™ for cats, horses and dogs. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.