OMT-28, a Phase 2 Clinical Candidate ready for evaluation in CV Inflammation and Mitochondriopathies
Our most advanced therapeutic candidate, OMT-28, has completed a Phase 2 clinical study for the prevention of atrial fibrillation. While the impact on atrial fibrillation was not sufficient to progress this indication, OMT-28 demonstrated a significant positive impact on a number of inflammatory biomarkers such as IL-6 and mitochondrial dysfunction marker GDF-15.
OMT-28 targets inflammation plus mitochondrial dysfunction, a unique mode of action. The clinical data, together with pre-clinical anti-inflammatory and anti-atherosclerotic data support the application of OMT-28 in the treatment of cardiometabolic syndromes. We are actively planning a proof of concept clinical study in patients with chronic inflammation in coronary artery disease on biomarkers of inflammation. In independent outcome studies, a reduction of these biomarkers has been directly associated with positive clinical outcomes.
OMEICOS is also actively planning a clinical program in myopathy/cardiomyopathy associated with rare mitochondrial diseases such as MELAS. We build on positive data on mitochondrial function in relevant models and the ability of OMT-28 to significantly reduce plasma levels of GDF-15, the strongest independent predictor of disease progression in primary mitochondrial disease patients.
OMT-28 is a stable synthetic small molecule analog of the omega-3 fatty acid metabolite 17,18-EEQ, which has a structure optimized to provide high efficacy, safety and oral bioavailability.
In a previously performed Phase 1 study, OMT-28 exhibited an excellent tolerability profile and showing no safety signals in vital signs or safety laboratory parameters up to the maximum dose tested of 60 mg. This excellent overall and also cardiovascular safety profile has been confirmed in our Phase 2 study with atrial fibrillation patients.
Broadening the Pipeline in Ophthalmology
In addition to the company’s development activities in the cardiovascular space, OMEICOS has begun branching out into additional indications, initially focusing on severe eye disorders.
Exploratory work with OMEICOS’ therapeutic candidates included the generation of preclinical data comparing our approach to the current standard-of-care, injections of anti-VEGF therapies directly into the eye.
In a widely used mouse model for wet AMD OMEICOS’ approach reduced the formation of abnormal blood vessels and the leakiness of these blood vessels typical for wet AMD.
The therapeutic effects of oral OMT-28 observed were comparable with the intravitreally applied anti-VEGF therapy, in this case Aflibercept. Considering that therapeutic compounds based on OMEICOS’ technology have the potential to be conveniently given to patients as a pill, avoiding the need for injections into the eye, these results provide a very solid basis for further development in these indications.