Can’t wait till this is a UPDATED PR!!!!
Jaguar Health (JAGX) Reports Majority of Subjects in Phase 3 OnTarget Trial for Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Therapy Chose to Continue on to Stage II
December 11, 2023 8:32 AM
Napo Pharmaceuticals (Napo), a Jaguar Health, Inc. (NASDAQ: JAGX) (Jaguar) family company, today 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.
"We are very pleased that a majority of subjects chose to continue on to Stage II while recognizing that their requirement to remain blinded would continue," said Lisa Conte, Jaguar's president and CEO. "We are deeply committed to all patients who participated in the OnTarget trial. We view them as key stakeholders and we thank them for their support and participation in this study."
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.
"Since all patient data will be included in the final locked database, we will remain blinded and will announce the comprehensive results of the full trial, including Stage II results, rather than proceeding with the original plan of announcing top line results for Stage I only. We expect the full trial results to be available in the first quarter of 2024," Conte said. "The clinical trial database includes patients with multiple solid tumor types, and the trial allowed the inclusion of 24 different targeted therapies, including multiple important mechanisms of action for targeted therapy drugs."
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.
