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 - Seite 2

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 on tyrosine kinase inhibitors (TKIs) suffer from diarrhea, depending on the TKI used.¹ 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.

"We are excited as any stakeholder to see the results. We own the expectation we set that data would be available in November 2023. We have to respect and abide by the requirements and Standard Operating Procedures of our third-party service providers and work with them as we meet GCP (Good Clinical Practice) requirements, particularly when conducting a complex global Phase 3 clinical trial," Conte said. "These service providers have important quality control procedures that take time and somewhat expand as the data analysis process progresses. We are working with all vendors that are critical to ensure the integrity of the data. Jaguar and Napo personnel continue to remain blinded to the study results at this time."

Napo's abstract outlining the design of the OnTarget trial, the importance of patient reported outcomes, and the neglected medical need of CIOB was the subject of a poster presentation on December 7, 2023 at the San Antonio Breast Cancer Symposium (SABCS). More than two dozen leading patient advocacy groups provided powerful voices at events hosted by Napo, highlighting the neglected need of mitigating diarrhea in patients receiving cancer therapies, and expressing strong support for the company's focus on patient quality of life.