Benzinga | Nov 25, 2020 08:05AM EST

Jaguar Health And Subsidiary Napo Pharmaceuticals 'planning to study, develop and commercialize crofelemer'



Jaguar Health, Inc. ("Jaguar" or the "Company") and its wholly-owned subsidiary, Napo Pharmaceuticals, Inc. ("Napo"), are planning to study, develop and commercialize crofelemer, the Company's novel proprietary drug, for an indication of inflammatory diarrhea, initially in Europe. The Company's focus on this new indication is driven primarily by the emergence of the long-hauler COVID-19-recovery patients, sometimes referred to as chronic COVID or post-acute COVID syndrome. The Company intends to focus its clinical exploration in Europe, where single-payer healthcare systems focus on preventative measures to diagnose and treat symptoms that can be a precursor to potentially chronic illness. Endpoints being explored would include prophylaxis and/or symptomatic relief of diarrhea, reduction in inflammatory gut markers, and reduction in viral fecal shedding. The Company intends to evaluate various pathways to develop and commercialize crofelemer for inflammatory diarrhea, including collaborative relationships, strategic partnerships, and/or licensing of crofelemer.



Mytesi (crofelemer) is a novel, first-in-class anti-secretory agent which has a basic normalizing effect locally on the gut, and this mechanism of action has the potential to benefit multiple disorders. The Mytesi (crofelemer) product is approved in the U.S. by the U.S. Food and Drug Administration for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy, which includes people living with HIV and enteropathy, an inflammatory chronic syndrome typically affecting long-term HIV/AIDS survivors. Mytesi is in development for multiple possible follow-on indications, including cancer therapy-related diarrhea, a rare disease indication for infants and children with congenital diarrheal disorders (CDD), a rare disease indication for adult and pediatric patients with short bowel syndrome (SBS), supportive care for inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), and idiopathic/functional diarrhea. As previously disclosed, Napo initiated its pivotal Phase 3 clinical trial of crofelemer (Mytesi) for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy ("cancer therapy-related diarrhea" (CTD)) this past October.