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Jaguar Announces Over-Enrollment in its Pivotal Phase 3 OnTarget Trial of Crofelemer for Prophylaxis of Cancer Therapy-Related Diarrhea
256-patient enrollment target met plus 11% over-enrollment; Primary endpoint based on patient reported outcomes from study expected in October 2023SAN
About this update from Jaguar Health, Inc.
[{"type":"text","content":"256-patient enrollment target met plus 11% over-enrollment; Primary endpoint based on patient reported outcomes from study expected in October 2023SAN FRANCISCO, CA / ACCESSWIRE / May 25, 2023 / Jaguar Health, Inc. (Nasdaq:JAGX) (\"Jaguar\" or the \"Company\") today announced that the Company has successfully over-enrolled its global, pivotal, Phase 3 OnTarget clinical trial of crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy with or without chemotherapy.\"As anticipated, we over-enrolled our ongoing placebo-controlled OnTarget trial by 11% after completion of the targeted enrollment of 256 patients,\" said Pravin Chaturvedi, PhD, Jaguar's Chair of the Scientific Advisory Board and Chief Scientific Officer, \"and we look forward to the expected availability of top line results from this study in October 2023.\"\"As we closed down enrollment, over-enrollment occurred as we permitted participating clinics to enroll additional eligible patients who were in the screening pipelines at some of the sites,\" said Lisa Conte, Jaguar's president and CEO. \"We're very happy to make this announcement shortly after Clinical Trials Day, which occurs on May 20th each year. The full potential of clinical research to change lives can only be unlocked when patients, clinical researchers, regulatory agencies, and industry work together, embrace each other's perspectives, and invest in shared goals. We are grateful both to the hundreds of cancer patients who participated in the OnTarget study and to all the sites and investigators in the U.S., Serbia, Georgia, Argentina, and Taiwan who helped us accomplish this important enrollment milestone.\"The 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 of cancer therapy-related diarrhea. This study will evaluate the benefit of crofelemer to prevent or substantially reduce the number of weekly loose/watery stools as a continuous measurement over the 12-week treatment period compared to placebo. By completing the targeted enrollment, the OnTarget study has approximately 90% power to detect the difference in the incidence and severity of diarrhea between crofelemer and placebo.The Company's expectation is that the double-blind placebo control...