The PMD-OPTION Study
OMEICOS’ lead OMT-28 reduces mitochondrial dysfunction and oxidative stress via activation of the AMPK/SIRT-1/PGC1-alpha axis leading to a significant reduction of mitochondrial stress marker GDF-15 and inflammation stress marker IL-6 in a Phase 2 study in patients with atrial fibrillation and in preclinical experiments. The safety of OMT-28 was confirmed already in 162 individuals.
In our clinical study PMD-OPTION the efficacy and safety of OMT-28 will be evaluated in patients with Primary Mitochondrial Disease (PMD).
The study is designed to learn more about how patients with PMD benefit from a treatment with OMT-28. Furthermore, a better understanding of the value of biomarkers in the development of new treatments for mitochondrial diseases shall be established.
The primary objective of the study is to evaluate the responder rate of patients showing a reduction of GDF-15. Treatment will be with OMT-28 at 24mg once daily. Analysis will be done by comparing the treatment phase with a 12-weeks ‘run-in phase’ without treatment. Safety and tolerability of OMT-28 will be evaluated as well.
The study will also evaluate a significant number of secondary and exploratory endpoints to determine the effect of OMT-28 on clinical symptoms, standard functional parameters of physical strength, heart function, quality of life, and key metabolic plasma biomarkers.
Patients may be eligible to participate in the study if they
- Are diagnosed with having a mitochondrial disease which is caused by a known gene mutation or deletion in the mitochondrial DNA
- And are suffering from myopathy (muscle weakness and/or exercise intolerance) and/or cardiomyopathy (heart disease)
- And are able to perform standard exercise tests (e.g. a 12 min walking test)
- And are not involved in any other ongoing clinical study.
The PMD-OPTION study is divided into 3 parts:
- Screening / run-in phase w/o treatment: 12 weeks
- Treatment Phase: 24 weeks
- Safety follow-up: 4 weeks
The total duration of the study is 40 weeks.
6 visits at the clinical study centers are planned during the study.
In case needed, support will be given for traveling and accommodation.
All patients who complete the screening / run-in phase will receive the study medication OMT-28 in the treatment phase.
Participation in the PMD-OPTION study
Currently clinical study centers are opened in Italy and Germany. A list of the clinical centers is available here.
This information will be updated when additional sites will be opened in EU.
OMEICOS contact: email@example.com
OMT-28, a Phase 2 Clinical Candidate, ready for evaluation in CV Inflammation
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.
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.