Jaguar Health announces completed analysis from Phase 3 OnTarget trial

Jaguar Health announced that the recently completed analysis of the prespecified subgroup of adult patients with breast cancer from the company’s Phase 3 OnTarget trial indicate that crofelemer achieved statistical significance in this subgroup. Patients with breast cancer accounted for nearly 180 of the 287 participants in this unprecedented prophylactic clinical trial recently conducted by Jaguar family company Napo Pharmaceuticals for diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy. “The breast cancer results from OnTarget are a responder analysis, as was the primary endpoint in the phase 3 ADVENT trial that led to FDA approval of crofelemer for its currently commercialized indication for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy,” said Lisa Conte, Jaguar’s president and CEO. “This data in breast cancer patients has been submitted to a relevant oncology conference by the study’s primary investigators, and a full study report for the breast cancer results is expected to be submitted to a peer-reviewed journal. Additional analyses of OnTarget prespecified subgroups are ongoing, and we believe data from additional analyses may result in future submissions to peer-reviewed forums.” As previously announced, the initial top line results from the OnTarget study showed that the multicenter, double-blind, placebo-controlled pivotal clinical trial did not meet its primary estimand for the prespecified analysis of all tumor types. The subgroup analysis in adult breast cancer patients demonstrates that crofelemer provides clinically meaningful improvement in this patient population, and suggests that crofelemer has the potential to help breast cancer patients to better adhere to their cancer therapies.