Biopharmaceutical company Omeicos Therapeutics has announced first-dosing in a Phase II clinical study assessing its lead programme OMT-28 in patients with persistent Atrial Fibrillation (AF).
OMT-28 is a stable synthetic small molecule analogue of the natural omega-3 fatty acid metabolite 17,18-EEQ, which has a structure optimised to offer high efficacy, safety, and oral bioavailability, Omeicos said.
The compound is claimed to have proven its anti-arrhythmic, cardioprotective and anti-fibrotic potential in different in-vivo models.
The placebo-controlled, double-blind, randomised Promise-AF study, which is expected to enrol about 120 patients via centers in four European countries, will assess the efficacy, safety, and population pharmacokinetics in patients with persistent AF.
Through the trial, the company intends to evaluate the efficacy and safety of three different dosage levels of OMT-28 administered once daily versus placebo and the drug’s impact on the maintenance of normal sinus rhythm in patients with persistent AF.
Omeicos Therapeutics chief scientific officer and CEO Dr Robert Fischer said: “In our first-in-man study, OMT-28 was shown to be safe with results strongly supporting OMT-28’s claim to have a low risk for pro-arrhythmia.
“We are thus very excited to further substantiate our clinical data set for OMT-28 in AF patients addressing a significant unmet medical need with a novel therapeutic approach. OMT-28 targets the process of intracellular calcium regulation and mitochondrial function to stabilise the heart’s rhythm and in addition provides a cardioprotective effect.
“This mechanism sets it apart from currently marketed anti-arrhythmic drugs with the potential to make a real difference for the millions of patients suffering from AF.”
The Promise-AF trial, which is expected to complete in the first half of 2020, will allow Omeicos to transition OMT-28 into a Phase III clinical evaluation.