Jaguar Health announces results of independent study on crofelemer

Jaguar Health announced that the results of an independent pilot phase 2 study of crofelemer for the management of neratinib-associated diarrhea in patients with HER2+ early-stage breast cancer indicate that crofelemer, the Company’s FDA approved drug, may be effective for the management of neratinib-induced diarrhea. The results of the study, which was designed by the study’s principal investigator, Jo Chien, MD, and published in the peer-reviewed journal Clinical Breast Cancer, are consistent with the results of a preclinical dog study evaluating the effects of crofelemer in improving diarrhea associated with neratinib, a tyrosine kinase inhibitor, presented at the American Association for Cancer Research Virtual Annual Meeting II in June 2020. “Seven patients underwent treatment with crofelemer and loperamide in this new study, 5 of whom were able to control diarrhea with crofelemer alone. Though this study involved a small number of patients, the results show activity of crofelemer for the management of neratinib-induced diarrhea, which warrants further investigation of crofelemer for treatment of cancer therapy-related diarrhea,” said study investigator Hope S. Rugo, MD, Professor of Medicine and Winterhof Family Professor of Breast Oncology, University of California San Francisco Helen Diller Family Comprehensive Cancer Center. Dr. Rugo is a member of the Company’s Scientific Advisory Board. This single center, open label trial enrolled patients with Stage 2 to 3 HER2+ breast cancer receiving neratinib in the extended adjuvant setting. One cohort took prophylactic crofelemer 125 mg bid and loperamide in the first 2 cycles, and as needed in the subsequent cycles. The second cohort received escalating doses of neratinib with loperamide. The primary endpoint was incidence of grade greater than or equal to3 diarrhea in the first 2 cycles. Top line results from the Company’s ongoing phase 3 OnTarget clinical trial are expected in late October 2023.