OMEICOS’ OMT-28 Headed for Phase 3 in Primary Mitochondrial Diseases (PMD) Following Positive End-of-Phase 2 Meeting with the FDABERLIN, GERMANY, July 21, 2026 – OMEICOS, a late-stage clinical biopharmaceutical company developing first-in-class small-molecule therapeutics for mitochondrial and inflammatory disorders, today announced the successful completion of the End-of-Phase 2 (EOP2) meeting with the FDA regarding the development of OMT-28 in Primary Mitochondrial Diseases (PMD). During the meeting, the FDA expressed strong support for OMEICOS’ plans to advance the program into late-stage clinical development and provided clear, constructive guidance to structure the next steps efficiently. As a result, OMEICOS is now positioned to advance its proprietary, fully owned lead product candidate OMT-28 directly into a pivotal Phase 3 study.
OMEICOS Therapeutics Completes Enrollment of PMD-OPTION Study in Primary Mitochondrial DiseaseInterim data confirms OMT-28’s strong safety profile in PMD patients, top-line data expected mid-2025
