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Napo Pharmaceuticals, a Jaguar Health Family Company, Reports Completion of Last Patient Last Visit for its Pivotal Phase 3 OnTarget Trial of Crofelemer for Preventive Treatment of Cancer Therapy-Related Diarrhea
Company on track to report top line data in late October 2023SAN FRANCISCO, CA / ACCESSWIRE / August 17, 2023 / Napo Pharmaceuticals (Napo), a Jaguar Health,
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Company on track to report top line data in late October 2023SAN FRANCISCO, CA / ACCESSWIRE / August 17, 2023 / Napo Pharmaceuticals (Napo), a Jaguar Health, Inc. (NASDAQ:JAGX) family company, today announced that the last patient has completed their final visit for the stage 1 primary endpoint treatment period of Napo's pivotal Phase 3 OnTarget trial of crofelemer for preventive treatment of diarrhea in adult cancer patients with solid tumors receiving targeted therapy with or without standard chemotherapy. This trial is studying an indication Napo also refers to as preventive treatment of chemotherapy-induced overactive bowel (CIOB) - which includes symptoms such as chronic debilitating diarrhea (loose and/or watery stools), urgency, and bowel incontinence. Top-line results for the primary endpoint in this trial are expected the last week of October 2023.\"The pivotal Phase 3 OnTarget trial of crofelemer for the preventive treatment of CIOB is our paramount near-term clinical milestone,\" said Lisa Conte, Jaguar's president and CEO, \"and we're very happy to be able to announce that the last enrolled participant in this global trial has completed their stage 1 final visit. The OnTarget trial is evaluating the same formulation of crofelemer that comprises Mytesi®, our FDA-approved, commercially available drug for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. This is a major milestone for the company and a key step on our journey to making crofelemer available to treat the critical and neglected medical need of CIOB. We are grateful to all the cancer patients who participated in the study and to all the clinical investigators in the U.S., Serbia, Georgia, Argentina, and Taiwan who helped us achieve this important milestone. Our mission is to address not only health issues associated with CIOB, but also to support the quality of life, comfort and dignity of patients living with targeted therapy treatment for months and years, and the ability of patients to be able to comply with their respective chronically administered regimens of targeted therapies.\"About the Phase 3 OnTarget Clinical TrialThe OnTarget study is a first-of-its-kind prophylactic clinical trial with a primary endpoint based on patient reported outcomes that address the highly neglected and unmet burden...