PROMISE-AF trial to deliver clinical proof-of-concept and determine Phase 3 dosing regimen for novel approach to stabilize the heart rhythm.
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 the dosing of a first patient in a Phase 2 clinical study for the company’s OMT-28 development program. The placebo-controlled, double-blind, randomized PROMISE-AF study will evaluate the efficacy, safety, and population pharmacokinetics in patients with persistent Atrial Fibrillation (AF). The 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.
“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.”
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. 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.
More information on the PROMISE-AF study is available on https://www.clinicaltrials.gov.
OMEICOS Therapeutics is a spin-off company from the Max Delbrueck Center for Molecular Medicine (MDC) 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 has been supported by a grant from the German Ministry of Education and Research (BMBF). www.omeicos.com
OMEICOS Therapeutics GmbH
Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
MacDougall Biomedical Communications
Mario Brkulj or Kara Mazey
Phone: +49 89 2424 3494 or +1 781-235-3060