OMEICOS Therapeutics Completes PMD-OPTION Study Enrollment in Primary Mitochondrial Disease

OMEICOS Achieves Key Milestone in Phase 2a PMD-OPTION Study of OMT-28

Berlin, Germany, September 26, 2024 – OMEICOS, a leading biopharmaceutical firm specializing in novel small molecule therapeutics, has announced the successful completion of patient enrollment for its Phase 2a PMD-OPTION study. This multi-center, open-label clinical trial focuses on assessing the efficacy of OMT-28 in patients diagnosed with Primary Mitochondrial Disease (PMD), specifically those experiencing myopathy and cardiomyopathy. The company anticipates releasing top-line data from the study by mid-2025.

Dr. Robert Fischer, CEO/CSO of OMEICOS Therapeutics, emphasized the significance of achieving the enrollment target within a year of the study's initiation. He expressed gratitude towards the patients and investigators involved, noting that the initial data analyses confirm OMT-28's strong safety profile and excellent tolerability in the patient cohort. The preliminary clinical data also appear promising concerning relevant endpoints, bolstering hopes for offering a new treatment option for PMD patients who are currently underserved by existing therapies.

The PMD-OPTION study's primary goals include evaluating the safety and tolerability of OMT-28 and measuring the response rate in patients showing at least a 20% reduction in Growth Differentiation Factor 15 (GDF-15) levels compared to baseline. GDF-15 is a biomarker produced in response to mitochondrial stress, inflammation, or hypoxia and is increasingly recognized as a significant risk predictor in various diseases, including cardiometabolic conditions and PMD. The study also investigates a range of secondary and exploratory endpoints to evaluate the impact of OMT-28 on clinical symptoms, physical strength, heart function, quality of life, and key metabolic biomarkers.

Patients with PMD face severe and life-threatening symptoms, such as drastically reduced physical stamina and disease-induced alterations in heart and skeletal muscles, often accompanied by neurological disorders. OMEICOS aims to enhance cell metabolism and mitochondrial function through its therapeutic strategy with OMT-28, thereby improving the quality of life for PMD patients and their families. The PMD-OPTION study enrolled 28 patients and includes a 12-week untreated run-in phase to capture natural history and baseline parameters. Following this phase, all patients receive a 24 mg once-daily dose of OMT-28 for up to 24 weeks.

About OMT-28

OMT-28 is a pioneering small molecule that has showcased cell-protective, anti-inflammatory, and anti-atherosclerotic properties. Preclinical and clinical data generated by OMEICOS demonstrate the compound's robust safety profile and tolerability, as well as its therapeutic potential in treating cardiovascular diseases linked to inflammation in atherosclerosis and cardiomyopathy, as well as other age-related conditions such as AMD. The ongoing PMD-OPTION Phase 2 clinical trial is assessing the efficacy of OMT-28 in patients with Primary Mitochondrial Disease.

About OMEICOS

OMEICOS Therapeutics has developed a series of metabolically stable synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids. These analogues have the potential to treat mitochondrial dysfunction, inflammatory, cardiovascular, and other diseases. Epoxyeicosanoids activate endogenous pathways specific to cell types, promoting organ and tissue protection. OMEICOS’ small molecules are orally available and exhibit enhanced biological activity and pharmacokinetic properties compared to their natural counterparts.