Matinas BioPharma reaches agreement with FDA for Phase 3 trial of MAT2203

Matinas BioPharma announces alignment with the U.S. Food and Drug Administration, FDA, on the design of a single Phase 3 registration trial of MAT2203 in patients with invasive aspergillosis who have limited treatment options, the ORLATO trial. The ORALTO trial design is built upon the successful Phase 2 EnACT trial that confirmed MAT2203’s efficacy and safety as a step-down and all-oral therapy in HIV patients with cryptococcal meningitis, as well as the Company’s ongoing Compassionate/Expanded Use Access Program in individuals suffering from severe invasive fungal infections with no other treatment options. “We are pleased to achieve alignment with the FDA on the design of a single Phase 3 trial to support the registration of MAT2203 for the treatment of invasive aspergillosis in patients with limited treatment options,” commented Dr. Theresa Matkovits, Chief Development Officer at Matinas. “We greatly appreciate the opportunity to work collaboratively with the FDA, which was essential for reaching consensus on all critical elements of the registrational path for MAT2203. Importantly, we view ORALTO as a registration trial with a high probability of clinical success given the ongoing positive patient clinical experience in our Compassionate/Expanded Use Access Program, which mirrors the patients to be enrolled in our upcoming Phase 3 registration trial.”