BERLIN--(BUSINESS WIRE)--OMEICOS Therapeutics, a Berlin-based biopharmaceutical company developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular and ophthalmic diseases, today announced results from its first-in-human clinical study for OMT-28. The study met its primary goal with OMT-28 exhibiting an excellent tolerability profile and showing no safety signals in vital signs or safety laboratory parameters up to the maximum dose tested, which was 60 mg. High-resolution electrocardiography recordings were used to detect any heartbeat anomalies such as QT-prolongations and changes in the PR and QRS intervals. OMT-28 did not have a clinically relevant effect on these heart rate parameters or on cardiac conduction at all doses tested in the trial which strongly supports OMT-28’s claim to have a low risk for pro-arrhythmia. With the Phase 1 trial concluded, OMEICOS has accelerated its plans to initiate a subsequent Phase 2 trial focused on maintenance of sinus rhythm in patients suffering from non-permanent Atrial Fibrillation.
“It is very encouraging to see that even at the highest dose tested for OMT-28, the regular heartbeat physiology in healthy volunteers remained intact, since the tendency of existing antiarrhythmic drugs to lead to the emergence of potentially life-threatening arrhythmias is a well-documented paradox,” said Robert Fischer, MD, CEO of OMEICOS Therapeutics. “We believe this further supports our claim that OMT-28 could become the first example of a complete novel class of drugs combining anti-arrhythmic, cardioprotective and anti-remodeling effects for long-term rhythm maintenance. With this data, the swift execution of our development plan for OMT-28 remains a top priority for OMEICOS and we are eager to initiate the subsequent Phase 2 trial in patients suffering from a common form of atrial fibrillation. Additionally, the results of our first-in-human study put us in a great position to unlock the tremendous potential of OMT-28 and the entire new molecule class in several other indications.”
OMEICOS’ lead compound, OMT-28, is a stable synthetic small molecule analog of the natural omega-3 fatty acid metabolite 17,18-EEQ, which has a structure optimized to provide high efficacy, safety, and oral bioavailability. OMT-28 has already proven its anti-arrhythmic, cardioprotective and anti-fibrotic potential in different in vivo models. The now concluded randomized, double-blind, placebo-controlled Phase 1 study was conducted at two centers in Germany and enrolled 75 subjects. The results of the first-in-human trial demonstrate that OMT-28’s pharmacokinetic profile allows a once-daily oral treatment. Additional parameters analyzed in the trial were the impact of the subject’s gender or diet on the uptake and metabolism of OMT-28.
For more information on the trial (NCT03078738) please visit https://clinicaltrials.gov.
OMEICOS Therapeutics is focused on developing a novel class of synthetic bioactive lipid mediators for the treatment of cardiovascular, ophthalmic and other chronic inflammatory diseases. OMEICOS’ compounds activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available but can be used in other application routes as well. OMEICOS has the exclusive, worldwide license for IP rights from Max Delbrueck Center for Molecular Medicine in Berlin, Germany, and UT Southwestern, Texas, USA, to develop its lead compound OMT-28 and has established a comprehensive pipeline of discovery and pre-clinical stage compounds. OMEICOS is financed by a strong consortium of private and public VC investors and its research activities are supported by a grant from the German Ministry of Education and Research (BMBF). For more information, please visit: www.omeicos.com