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Jaguar Health Achieves Approximately 75% Enrollment in Pivotal Phase 3 OnTarget Trial of Crofelemer for Cancer Therapy-Related Diarrhea
Addition of OnTarget trial sites in Europe, South America and Asia has significantly accelerated enrollment, which is expected to complete in Q2 2023Adoption
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Addition of OnTarget trial sites in Europe, South America and Asia has significantly accelerated enrollment, which is expected to complete in Q2 2023Adoption of premier digital health technology for data collection facilitates operational efficiency of this global trialSAN FRANCISCO, CA / ACCESSWIRE / February 21, 2023 / Jaguar Health, Inc. (Nasdaq:JAGX) (\"Jaguar\" or the \"Company\") today announced that patient enrollment has reached approximately 75% in the Company's pivotal Phase 3 OnTarget clinical trial of crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy, with or without chemotherapy. Target trial enrollment of 256 patients is expected to complete in the second quarter of 2023.Crofelemer, the Company's oral botanical drug, is an anti-secretory antidiarrheal agent that modulates gastrointestinal (GI) chloride ion channels to ameliorate diarrhea. It is marketed as Mytesi® and received approval from the U.S. Food and Drug Administration (FDA) for its initial indication of the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.\"We are very excited that enrollment in OnTarget has reached approximately 75%. Our efforts over the past year to expand the trial to new U.S. and international sites - with trial sites now active in Georgia, the Republic of Serbia, Argentina, and Taiwan - has significantly accelerated enrollment,\" said Darlene Horton, MD, the Company's Chief Medical Officer. \"Additionally, I am pleased to report that our original decision to leverage premier digital health technology for data collection in OnTarget greatly facilitates the operational efficiency of a global trial. Our expectation is that the placebo-controlled OnTarget trial will provide evidence that diarrhea associated with targeted cancer therapies is chronic, not acute, and impacts the patient's ability to remain on their cancer therapy regimens at proven doses for better outcomes. The OnTarget trial is evaluating the effectiveness of crofelemer's novel mechanism of action - the modulation of two chloride ion channels in the gastrointestinal tract - to mitigate or substantially reduce chronic cancer therapy-related diarrhea.\"About Cancer Therapy-Related DiarrheaA significant proportion of patients undergoing cancer therapy experience diarrhea, and diarr...