High-resolution electrocardiography strongly supports OMT-28’s claim for low pro-arrhythmic risk
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 heart beat 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 heart beat 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-remodelling 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 GmbH Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
MacDougall Biomedical Communications
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