BERLIN, GERMANY, June 21, 2023 – OMEICOS, a biopharmaceutical company developing first-in-class small molecule therapeutics based on the profound understanding of omega-3 fatty acid metabolism and physiology, announced today that the Company has received a significant grant by the German Federal Ministry of Education and Research (“BMBF”) strongly supporting the development of OMEICOS’ lead product candidate OMT-28*. The funding provided under the “KMU-innovativ: Biomedizin” program will be used to co-finance the upcoming Phase 2a clinical study evaluating OMT-28 in Primary Mitochondrial Disease (PMD) patients. The study will be conducted in leading European clinical centers for mitochondria-related pathologies. In April 2023, OMEICOS had received first approvals of the study design from the respective regulatory authorities.
“Securing the funding to complement our own investment in the upcoming Phase 2a is a major achievement for the team and will boost our ability to demonstrate OMT-28’s potential in PMD. Beyond the strong financial support, the BMBF’s decision adds further validation to our approach of expanding the clinical development of OMT-28 into this indication,” commented Dr. Robert Fischer, CEO/CSO of OMEICOS Therapeutics. “We are on track with our first clinical study in PMD, which will allow us to generate meaningful safety data and show the drug’s impact on a set of clinically relevant parameters. As a rare disease with no or only insufficient treatment options available, bringing innovation and novel therapeutic concepts to PMD patients and their families quickly is crucial.”
PMD patients suffer from debilitating and life-threatening health consequences, such as severely limited physical stamina and disease-related changes in the heart and skeletal muscles, as well as associated neurological disorders. In preclinical in vitro and in vivo tests, the positive influence of OMT-28 on mitochondrial function and its impact on inflammatory processes associated with the condition has been demonstrated. As part of OMEICOS development activities in cardiovascular diseases, OMT-28 had previously shown an excellent safety profile in two clinical trials and 162 individuals in total. Profound effects on key biomarkers of metabolic and inflammatory stress such as GDF-15, IL-6, PTX-3 and hs-CRP observed in these studies provide a very promising scientific rationale for the translation of the therapeutic concept into mitochondrial health.
OMEICOS Therapeutics has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat mitochondrial dysfunction, inflammatory, cardiovascular and other diseases. Epoxyeicosanoids activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. For more, please visit: www.omeicos.com
OMEICOS Therapeutics GmbH
Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
Phone: +49 (0) 160 93529951
* This project receives funding from the German Federal Ministry of Education and Research under
the “KMU-innovativ: Biomedizin” program