Pablo Okhuysen, MD, FACP, FIDSA of MD Anderson discusses the Jaguar Health Subsidiary Napo Pharmaceuticals Initiates Pivotal Phase 3 Clinical Trial of Crofelemer (Mytesi) for Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy
SAN FRANCISCO, CA / ACCESSWIRE / October 7, 2020, / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that its wholly-owned subsidiary, Napo Pharmaceuticals, Inc. (Napo), has launched its cornerstone crofelemer (Mytesi®) Phase 3 clinical trial for diarrhea prophylaxis in adult cancer patients undergoing targeted therapy ('cancer treatment-related diarrhea' (CTD)).
The Phase 3 pivotal clinical trial is a 24-week, randomized placebo-controlled, double-blind, 24-week (two 12-week stages) trial assessing the safety and efficacy of crofelemer (Mytesi) in the prophylaxis of diarrhea in adult cancer patients with solid tumors undergoing treatment regimens containing targeted cancer therapy. Treatment with Crofelemer or placebo will begin simultaneously with the intended regimen of cancer therapy. At the end of the initial (Stage I) 12-week double-blind, placebo-controlled primary treatment process, the primary endpoint will be assessed. After completing the treatment phase of Stage I, subjects would have the option of staying in their allocated treatment arm and consenting to join the 12-week extension phase of Stage II. In adult cancer patients undergoing targeted cancer therapies with or without conventional chemotherapy regimens, the safety and efficacy of orally administered crofelemer will be tested for the prophylaxis of diarrhea. The diarrhea frequency assessment will be determined by the amount of loose and/or watery stools for the treatment duration of Stage I. On the clinicaltrials.gov website, more information about the study can be viewed. The trial's National Clinical Trial number is NCT04538625.
At the University of Texas, MD Anderson Cancer Center in Houston, TX, Dr. Okhuysen is Professor of Medicine, Department of Infectious Diseases, Infection Prevention and Employee Welfare, Division of Internal Medicine.
About 650,000 cancer patients in the U.S. undergo chemotherapy at an outpatient oncology clinic each year, according to the Centers for Disease Control and Prevention (CDC). A large proportion of cancer therapy patients experience diarrhea, and diarrhea in this population has the potential to cause dehydration, potential infections, and non-adherence to care.
The novel 'targeted cancer therapy' agents, such as antibodies to the epidermal growth factor receptor (EGFR) and tyrosine kinase inhibitors (TKIs), can activate intestinal chloride ion channel-mediated secretory pathways with or without cycle chemotherapy agents, resulting in an increased electrolyte and fluid content in the gut lumen resulting in the passage of loose/watery stools (i.e. secretory diarrhea). Diarrhea, including the recently approved irreversible pan-HER TKI neratinib (Nerlynx®), has been identified as one of the most common side effects of TKIs, with occurrences ranging from 86% to >95% in published studies. A common side effect of some CDK 4/6 inhibitors is diarrhea as well.
Mytesi is a non-opiate, plant-based antidiarrheal modulating chloride ion channel drug approved by the FDA for the symptomatic relief of non-infectious diarrhea in adult HIV/AIDS patients undergoing antiretroviral therapy. Mytesi has a novel mechanism of action that works locally in the gut by gently and efficiently modulating and normalizing the flow of water and electrolytes with limited systemic absorption, and is the only oral plant-based prescription medicine approved under FDA Botanical Guidance. Crofelemer has been purified by scientists from Napo and is obtained sustainably from the Amazon Rainforest.