OMEICOS Therapeutics Announces Expansion of OMT-28 Clinical Development Program into Primary Mitochondrial Diseases

08.12.2022 / OMT-28’s established safety profile, biomarker data, and funding secured from existing investors enable swift transition into a Phase II clinical study

OMEICOS, a biopharmaceutical company developing first-in-class small molecule therapeutics based on the reimagining of omega-3 fatty acid metabolism and physiology, announced the closing of a new financing round and the expansion of its clinical development activities into an indication with high unmet medical need - Primary Mitochondrial Disease (PMD). The financing, led by Remiges Ventures, Vesalius Biocapital and SMS group GmbH, will allow OMEICOS to advance its lead program, OMT-28, into a first Phase II study in PMD patients in H1 2023. OMT-28 had shown an excellent safety profile in two clinical trials and 162 individuals in total and profound effects on key biomarkers of metabolic and inflammatory stress such as GDF-15, IL-6, PTX-3 and hs-CRP.

“The expansion of OMT-28’s clinical development program into PMD will allow us to gain further evidence on the compound’s capability to target mitochondrial dysfunction and associated inflammation as well as to obtain first clinical response data from this group of severely affected patients that still have very limited treatment options”, commented Dr. Robert Fischer, CEO/CSO of OMEICOS Therapeutics. “With the initiation of the upcoming Phase II study in PMD, OMEICOS is immediately positioned as a clinical-stage developer in an attractive rare disease market with a significant unmet medical need. In this indication, OMEICOS benefits from the unique blend of expertise in cardiology and muscle cell physiology combined with the profound understanding of the multimodal effects of our molecules in metabolic and inflammatory stress pathways.”

Defects of the mitochondrial oxidative phosphorylation system (OXPHOS) results in oxidative and reductive stress and chronic activation of pro-inflammatory pathways, leading to disease progression and ultimately reduced life expectancy in many indications, including PMD. While PMD’s are a highly heterogeneous group of diseases, high energy requiring tissue and organs are most affected and as a consequence, myopathies and cardiomyopathies represent two of the key hallmarks in several PMD patient populations.

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.

Source :Press Release Omeicos
OMEICOS Therapeutics Announces Expansion of OMT-28 Clinical Development Program into Primary Mitochondrial Diseases
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