Jaguar Health Gains FDA Support for Single-Blind Extension of Crofelemer MVID Trial
The FDA has approved Jaguar Health’s protocol amendment to initiate a single-blind extension phase of its crofelemer trial in pediatric MVID patients to assess longer-term safety and efficacy. Approximately 30% of participants have completed the double-blind phase, and regulatory consents span US, EU, UAE and Italian authorities.
1. FDA Support and Trial Extension
Jaguar Health received FDA feedback endorsing a protocol amendment to launch a single-blind extension phase of its crofelemer powder-for-oral-solution trial in pediatric patients with microvillus inclusion disease. This phase will allow subjects who finished the double-blind period to continue treatment and evaluate extended safety and efficacy.
2. Patient Enrollment and Study Design
Dose selection for the extension phase will be determined by an independent Data Monitoring Committee to maintain blinding. Currently, about 30% of enrolled MVID patients have completed the double-blind treatment and are eligible for the extended single-blind segment.
3. Global Regulatory Consents
The trial extension has secured approvals from the US FDA, European Medicines Agency, the UAE Ministry of Health and Prevention, Italian Ministry of Health and relevant Institutional Review Boards. Clinical sites are active in the US, Italy and the UAE.
4. Potential Breakthrough Therapy Pathway
Jaguar Health plans to leverage extended treatment data to pursue FDA Breakthrough Therapy designation, which could support expedited regulatory review and potential accelerated approval for crofelemer in this ultrarare pediatric disorder.