The Berlin-based biotech company is developing OMT-28 for the treatment of Primary Mitochondrial Diseases (PMD). These rare genetic metabolic disorders can severely limit physical performance and may damage the heart, skeletal muscles and nervous system. At present, no FDA-approved therapy is available for the vast majority of affected patients. OMT-28 is administered orally and is designed to influence both redox balance and mitochondrial restoration through a dual mechanism of action.
The positive regulatory feedback was based on the results of the multicentre, open-label Phase IIa PMD-OPTION study. According to OMEICOS, the findings indicate an improvement in physical condition among responding patients, accompanied by recovery of impaired mitochondrial function. In addition, the study confirmed the favourable safety and tolerability profile of OMT-28, which has so far been evaluated in several studies involving more than 190 individuals.
The FDA’s decision represents an important achievement for OMEICOS. The company had originally developed OMT-28 for the treatment of cardiovascular diseases. After this indication proved clinically less promising than anticipated, the company undertook a fundamental strategic shift in 2022 and refocused its development efforts on rare mitochondrial disorders. Existing investors supported this strategic shift and provided funding for further development.
The planned pivotal Phase III study is set to enrol up to 160 adults, representing the most important PMD subgroups.
OMEICOS is a spin-off from the Max Delbrück Center. As the Max Delbrück Center’s technology transfer partner, Ascenion has accompanied the project from the outset and holds equity in the company.
Further information: OMEICOS’ press release
