Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") and the Company's wholly-owned subsidiary, Napo Pharmaceuticals, Inc. (Napo), announced today that Jaguar and Napo are planning to develop and commercialize crofelemer, the Company's novel proprietary drug, for an indication of prophylaxis and/or symptomatic relief of inflammatory diarrhea, initially to be studied in a ‘long-hauler' COVID-19 recovery patient population in Europe.
The terms "long-hauler" and "chronic COVID" refer to COVID-19 survivors who suffer with symptoms which may include gastrointestinal distress (i.e. diarrhea, constipation, nausea, pain), fatigue, brain fog, forgetfulness, cardiovascular effects, and arthritis, for an extended period after recovery. It is theorized that these symptoms may result when the immune system in COVID-19 survivors continues to overreact even though the infection has passed. Long-hauler syndrome appears to be predominant in younger COVID-19 recovery patients and those who experienced a mild/asymptomatic case.
Inflammation in the GI track often manifests as diarrhea, and chronic diarrhea may be an observable symptom that can provide for early diagnosis of long-hauler syndrome. Early diagnosis of chronic COVID syndrome could help limit the burden of long-term chronic illness in COVID-19 recovery patients.
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. Mytesi is a non-opiate, plant-based, chloride ion channel modulating antidiarrheal medicine that is approved in the U.S. by the Food and Drug Administration (FDA) for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.
Mytesi is also in development for multiple possible follow-on indications, including cancer therapy-related diarrhea, a rare disease indication for adult 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. Crofelemer in pediatric liquid formulation is in development for a rare disease indication for infants and children with congenital diarrhea disorders (CDD) and pediatric SBS.