Napo Pharmaceuticals (Napo), a Jaguar Health, Inc. (NASDAQ:JAGX) family company, today announced that the company has not yet been provided with results from the company's GCP (Good Clinical Practice) vendors supporting Napo's pivotal Phase 3 OnTarget trial. The trial is evaluating the company's plant-based prescription drug crofelemer for prophylaxis of diarrhea in adult cancer patients with solid tumors receiving targeted therapy, with or without standard chemotherapy. The top line results of the study are forthcoming.
"Napo and all key study-related personnel remain blinded to study results at this time. The OnTarget trial is our paramount near-term clinical milestone," said Lisa Conte, Jaguar's president and CEO. "We look forward to announcing and presenting the top line results when they are available."
The company's abstract outlining the design of the OnTarget trial and the neglected medical need has been accepted by the December 2023 San Antonio Breast Cancer Symposium. Diarrhea is a common side effect of targeted therapies and new treatments are needed.
About the Phase 3 OnTarget Clinical Trial
The multicenter double-blind, placebo-controlled 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 chemotherapy-induced overactive bowel (CIOB), including specifically diarrhea/loose watery stools. The study evaluated the efficacy of crofelemer, a botanical drug that modulates intestinal chloride ion channels, for its ability to prevent or substantially reduce cancer therapy-related diarrhea and symptoms of CIOB over the 12-week treatment period, compared to placebo.
Crofelemer is the only oral prescription drug approved under FDA botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon rainforest. Jaguar family company Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities.