OMEICOS Therapeutics, a Berlin-based biopharmaceutical company that specializes in cardiovascular and ophthalmic diseases, has announced the dosing of a first patient in a Phase 2 clinical study for the company’s Omega 3 derived metabolite, OMT-28.

The study ( titled PROMISE-AF ) is a placebo-controlled, double-blind, and randomized trial designed to evaluate the efficacy, safety, and pharmacokinetics of OMT-28 in patients with persistent Atrial Fibrillation (AF). The study aims to enroll up to 120 patients in four European countries.

From the press release: “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,” said Dr. Robert Fischer, Chief Executive Officer and Chief Scientific Officer of OMEICOS Therapeutics. “OMT-28 targets the process of intracellular calcium regulation and mitochondrial function to stabilize 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. Since our therapeutic platform targets one of nature’s most important cell-protective pathways, clinical evaluation of OMT-28 in cardiovascular diseases could very well act as the cornerstone to branch out into multiple other indications.”

Our take..

Here at regenerative times, we find OMT-28 interesting, because it is essentially a metabolite from omega 3 fatty acids, which the western diet is generally deficient in, or dis balanced by a diet rich in inflammatory omega 6 fatty acids from industrial seed oils. Proponents of paleolithic diets generally agree that omega 6 is a main driver of heart disease and many inflammation-driven diseases; thus, restoring omega 3 – omega 6 balance may be the cure.

Omega 6 – Omega 3 balance of common foods.

Studies of Omega 3 supplements such as fish oil have shown many of the same benefits that OMT-28 promises to bring – the stabilization of electrical signaling in the heart. Even the American Heart Association has published papers in favor of omega 3 supplementation for Atrial Fibrillation. Unfortunately, most research on omega 3 supplementation comes from observational studies.

OMT-28 may end up being the pharmaceutical equivalent to a high dose of inexpensive fish oil. If developed into a commercial therapy, it may be a confirmation of what diet-focused health advocates have been saying for decades. We support the approach and will be following the results, regardless.

For more information, you can see OMEICOS Therapeutics’ press release here: http://omeicos.com/omeicos-initiates-phase2-clinical-trial-for-lead-compound-omt-28-in-atrial-filibration/

