A Majority of Subjects in Jaguar Health's Placebo-Controlled Pivotal Phase 3 OnTarget Trial for Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Therapy Chose to Continue on to Stage II

Stage II completed; comprehensive results expected in Q1 2024; company's planned regulatory pathway for FDA approval remains on track

Cancer patients at patient advocacy events voice strong support for company's focus on patient quality of life and the highly neglected need for new therapies for cancer therapy-related diarrhea

SAN FRANCISCO, CA / ACCESSWIRE / December 11, 2023 / Napo Pharmaceuticals (Napo), a Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company, today announced that a majority of subjects in the company's placebo-controlled pivotal Phase 3 OnTarget trial for prophylaxis (prevention) of diarrhea in adult cancer patients receiving targeted therapy with or without standard chemotherapy chose to continue on to Stage II of the two-stage trial.

After completing the Stage I double-blind, placebo-controlled primary prophylactic treatment phase of OnTarget, subjects had the option to remain on their blinded assigned treatment arm and reconsent to enter into the Stage II extension phase.

"We are very pleased that a majority of subjects chose to continue on to Stage II while recognizing that their requirement to remain blinded would continue," said Lisa Conte, Jaguar's president and CEO. "We are deeply committed to all patients who participated in the OnTarget trial. We view them as key stakeholders and we thank them for their support and participation in this study."

Stage II of the trial has concluded. Inclusion of Stage I data and Stage II data, with success, is required in the supplemental NDA filing of crofelemer to add the indication for prophylaxis of diarrhea in cancer patients receiving targeted therapy with or without standard chemotherapy.

"Since all patient data will be included in the final locked database, we will remain blinded and will announce the comprehensive results of the full trial, including Stage II results, rather than proceeding with the original plan of announcing top line results for Stage I only. We expect the full trial results to be available in the first quarter of 2024," Conte said. "The clinical trial database includes patients with multiple solid tumor types, and the trial allowed the inclusion of 24 different targeted therapies, including multiple important mechanisms of action for targeted therapy drugs."