Targeting Both Inflammation and Mitochondrial Dysfunction to Address Diseases With High Unmet Need

OMEICOS is focused on developing therapies that have the potential for a significant impact on cardiovascular, inflammatory and mitochondrial diseases with high unmet need. Our pipeline is based on our proprietary approach to target one of nature’s most important cell-protective pathways and industry-leading knowledge of omega-3 fatty acid metabolism and biology.

Our lead compound OMT-28 has successfully concluded the Phase 2a proof-of-concept study in Primary Mitochondrial Disease (PMD). The „PMD-OPTION“ study demonstrated OMT-28’s therapeutic potential to improve the physical condition in patients with PMD based on significant recovery of the impaired mitochondrial function in the responding patients. The study also further underscored the excellent safety and tolerability profile of OMT-28, which has been evaluated in more than 190 individuals to date. Subsequently, the program has received strong endorsement from the U.S. Food and Drug Administration (FDA) in an End-of-Phase 2 (EOP2) meeting and as a result is now positioned to advance directly into a pivotal Phase 3 study.

OMT-28 had previously been evaluated in a double-blinded, placebo-controlled, multi-center Phase 2 clinical trial in patients suffering from atrial fibrillation. In this study, OMT-28 demonstrated an excellent safety and tolerability profile, confirming the results of a Phase I „first-in-human“ trial with 75 healthy volunteers.

In addition, the study demonstrated a significant positive effect on a number of inflammatory biomarkers, among them GDF-15 and IL-6, the strongest independent predictors of mortality and disease progression in cardiovascular diseases.

OMT-28 has shown therapeutic potential in other disease areas such as ophthalmology.