Napo says majority of subjects in Phase 3 OnTarget trial continue to Stage II

Napo Pharmaceuticals announced that a majority of subjects in the company’s placebo-controlled pivotal Phase 3 OnTarget trial for prophylaxis 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. 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. OnTarget is a first-of-its-kind, 24-week clinical trial with a primary endpoint based on patient-reported outcomes that address the highly neglected and unmet burden of cancer therapy-related diarrhea, an indication Napo also refers to as preventive treatment of chemotherapy-induced overactive bowel – which includes symptoms such as chronic and/or episodic debilitating diarrhea urgency, bowel incontinence and abdominal pain and discomfort. Diarrhea is a common side effect of targeted therapies and new treatments are needed. Up to 95% of patients on tyrosine kinase inhibitors r from diarrhea, depending on the TKI used.1 The OnTarget study is testing whether the company’s plant-based prescription drug crofelemer can prevent diarrhea and other symptoms of CIOB when any one of the selected 24 different targeted therapies is initiated.