regulatory
confidence high
sentiment positive
materiality 0.80
FDA agrees on Phase 3 trial design for Matinas' MAT2203 in invasive aspergillosis
Matinas BioPharma Holdings, Inc.
- FDA agreed on design of single Phase 3 ORALTO trial for MAT2203 in invasive aspergillosis; primary endpoint all-cause mortality at day 42.
- Trial will enroll ~216 adults with limited treatment options; 2:1 randomization to oral MAT2203 vs continued AmBisome + SOC.
- Key secondary endpoint: superiority of MAT2203 over AmBisome for treatment-related toxicities leading to treatment changes.
- Enrollment expected to begin H2 2024, complete in ~24 months at ~65 sites across US, Europe, South America, Middle East, Asia Pacific.
- CEO says FDA alignment provides certainty to advance partnership discussions; product not yet approved.