Jaguar Health has reported statistically significant results from a responder analysis of breast cancer patients in its recently completed Phase 3 OnTarget trial of crofelemer, marking a potential breakthrough for the plant-derived therapeutic in oncology supportive care. The company is preparing to meet with the FDA in May 2025 to review these findings and discuss the regulatory pathway forward.
FDA Meeting to Review Positive Subgroup Analysis
The upcoming FDA meeting will focus specifically on the statistically significant responder analysis results observed in the breast cancer patient subgroup from the Phase 3 OnTarget trial. This development represents a significant milestone for crofelemer, which is currently FDA-approved under the brand name Mytesi for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.
Orphan Disease Designation Potential
According to Jaguar Health, the currently estimated US metastatic breast cancer population potentially qualifies as an orphan population, which aligns with the company's core strategic focus on orphan diseases. This designation could provide regulatory advantages and expedited development pathways for crofelemer in this indication.
Expanded Access Program Plans
The company plans to promptly pursue authorization to initiate an expanded access program for patients with breast cancer who may not be eligible for a potential pivotal treatment trial with crofelemer in metastatic breast cancer. This compassionate use program would provide treatment access to patients with limited therapeutic options while the company advances its regulatory strategy.
About Crofelemer and Jaguar Health
Crofelemer is a novel prescription medicine sustainably derived from plants from rainforest areas, developed by Jaguar's subsidiary Napo Pharmaceuticals for gastrointestinal distress associated with overactive bowel symptoms. The drug addresses symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain across multiple disease states.
Jaguar Health operates as a commercial-stage pharmaceutical company focused on developing proprietary prescription medicines from rainforest-derived plants. The company's family includes Napo Pharmaceuticals for human prescription pharmaceuticals, Napo Therapeutics for European expansion particularly in orphan diseases, and Magdalena Biosciences, a joint venture focused on plant-derived medicines for mental health indications.
