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.

“OMT-28 was shown to be safe with results strongly supporting OMT-28’s claim to have a low risk for pro-arrhythmia.”

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.