Napo Pharmaceuticals (Napo) 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. OnTarget is a first-of-its-kind, 24-week (two 12-week stages) 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 (CIOB) - which includes symptoms such as chronic and/or episodic debilitating diarrhea (loose and/or watery stools), 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 ontyrosine kinase inhibitors (TKIs) suffer from diarrhea, depending on the TKI used. The OnTarget study is testing whether the company's plant-based prescription drug crofelemer (versus placebo) can prevent (or substantially reduce) diarrhea and other symptoms of CIOB when any one of the selected 24 different targeted therapies (that are associated with diarrhea in at least 50% of patients) is initiated.

The company own the expectation the company set that data would be available in November 2023.