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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
A Significant Proportion of Patients Receiving Targeted Cancer Therapy Experience DiarrheaInitial Tranche of Non-dilutive Financing Transaction Increased from
About this update from Jaguar Health, Inc.
[{"type":"text","content":"A Significant Proportion of Patients Receiving Targeted Cancer Therapy Experience DiarrheaInitial Tranche of Non-dilutive Financing Transaction Increased from $5 Million to $6 Million by Mutual Consent with Lender, Providing Additional Q4 2020 Funding for Pivotal Phase 3 Clinical Trial and a Total Potential of $17 MillionSAN FRANCISCO, CA / ACCESSWIRE / October 7, 2020 / Jaguar Health, Inc. (NASDAQ:JAGX) announced today that the company's wholly owned subsidiary, Napo Pharmaceuticals, Inc. (Napo), has 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)).The Phase 3 pivotal clinical trial is a 24-week (two 12-week stages), randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of crofelemer (Mytesi) in providing prophylaxis of diarrhea in adult cancer patients with solid tumors receiving targeted cancer therapy-containing treatment regimens. Crofelemer or placebo treatment will start concurrently with the targeted cancer therapy regimen. The primary endpoint will be assessed at the end of the initial (Stage I) 12-week double-blind placebo-controlled primary treatment phase. After completing the Stage I treatment phase, the subjects will have the option to remain on their assigned treatment arm and reconsent to enter into the Stage II 12-week extension phase. The safety and efficacy of orally administered crofelemer will be evaluated for the prophylaxis of diarrhea in adult cancer patients receiving targeted cancer therapies with or without standard chemotherapy regimens. The assessment of the frequency of diarrhea will be measured by the number of loose and/or watery stools for the Stage I treatment period. Additional details about the trial can be viewed on the clinicaltrials.gov website. The National Clinical Trial number for the trial is NCT04538625.\"The initiation of this pivotal Phase 3 clinical trial for prophylaxis of diarrhea in cancer patients receiving targeted therapy regimens is a key milestone for Mytesi as we evaluate its potential to prevent and/or mitigate the intensity and severity of diarrhea experienced by cancer patients receiving targeted cancer therapy regimens, which may include various combinations with standard chemotherapy regimens,\"...