30 April 2019 - - German biopharmaceutical company Omeicos Therapeutics has dosed the first patient in a Phase 2 clinical study for the company's OMT-28 development programme, the company said.

The placebo-controlled, double-blind, randomized PROMISE-AF study will evaluate the efficacy, safety, and population pharmacokinetics in patients with persistent Atrial Fibrillation.

This study is expected to enroll up to 120 patients via centers in four European countries.

The completion of the PROMISE-AF trial is expected for H1 2020 and should enable Omeicos to transition OMT-28 into Phase III clinical evaluation.

OMT-28 is a stable synthetic small molecule analog of the natural omega-3 fatty acid metabolite 17,18-EEQ, which has a structure optimised to provide high efficacy, safety and oral bioavailability.

The compound has already proven its anti-arrhythmic, cardioprotective and anti-fibrotic potential in different in vivo models.

The primary goal of the PROMISE-AF trial is to evaluate the efficacy and safety of three different dose 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.

To accurately detect and monitor arrhythmias and assess the AF burden for patients, data will be collected via an implantable cardiac monitor provided by Berlin-based medical device specialist Biotronik.

Omeicos Therapeutics is a spin-off company from the Max Delbrueck Center for Molecular Medicine in Berlin.

The company has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat inflammatory, cardiovascular and other diseases.

Epoxyeicosanoids, as a newly described class of bioactive lipid mediators, target one of nature's most important cell-protective pathways, promoting organ and tissue protection.

Omeicos' small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts.

Omeicos' technology is based on ground-breaking scientific results in the field of omega-3 fatty acid metabolism and physiology obtained by the companies' founders, Dr. Wolf-Hagen Schunck, Prof. John. R. Falck, Prof. Dominik Mueller and Dr. Robert Fischer.

The companies' research activities have been supported by a grant from the German Ministry of Education and Research.