Trial Results Support Transition into Late-Stage Development with Program Expected to be Phase 2b/3-ready in H2 2026

BERLIN, GERMANY, January 29, 2026 – OMEICOS, a clinical-stage biopharmaceutical company developing first-in-class small molecule therapeutics for mitochondrial and inflammatory disorders, announced the successful conclusion of its multi-centre, open-label Phase 2a PMD-OPTION Study evaluating its lead program OMT-28 in patients with Primary Mitochondrial Disease (PMD). The study results demonstrate OMT-28’s therapeutic potential to improve the physical condition in PMD based on significant recovery of the impaired mitochondrial fitness in the responding patients. The study further underscored the excellent safety and tolerability profile of OMT-28, which has now been evaluated in more than 220 individuals. OMEICOS is preparing for a potentially pivotal Phase 2b/3 study in PMD patients with myopathy and/or cardiomyopathy across EU and US sites and expects to be ready to initiate this study later this year, subject to the completion of partnering discussions.

PMD represents a heterogeneous group of conditions including the more prevalent subtypes MELAS, non-MELAS, and MIDD. PMD patients suffer from debilitating and life-threatening health consequences, such as severely limited physical stamina and disease-related changes in the heart and skeletal muscles, as well as associated neurological disorders. OMT-28, an orally available biased modulator, targets the GPCR-receptor S1PR1 (Sphingosine-1-Phosphate Receptor 1 thereby driving downstream activation of the mitochondrial sirtuin family members SIRT1 and SIRT3. By targeting S1PR1 and activating SIRT1/SIRT3, OMT-28 combines immunomodulation with mitochondrial protection—a dual mechanism to tackle inflammation and energy deficits in primary mitochondrial diseases.

“Improving physical performance through enhanced mitochondrial metabolism and reduced oxidative stress holds great promise in PMD. Our PMD-OPTION study results indicate a strong correlation between OMT-28 treatment, the observed positive impact on mitochondrial bioenergetics and fitness, and relevant clinical improvements in functional measures, which could translate into significant patient benefit,” said Dr. Robert Fischer, CEO/CSO of OMEICOS Therapeutics. “The profound effects on NAD⁺ and GSH levels, as well as simultaneous improvement of the NAD⁺/NADH and GSH/GSSG ratios we have seen in the responder group, are integrative indicators of electron transport chain function improvements and cellular redox homeostasis. Overall, the results offer a robust path for late-stage development.”

Study Design and Results Summary

The PMD-OPTION study enrolled a total of 29 PMD patients with mitochondrial tRNA point mutations or single mtDNA deletions across nine expert sites in Germany, Italy, and The Netherlands. The study generated strong interest among patients and key opinion leaders (KOLs), resulting in timely recruitment and a high degree of compliance with the study protocol and follow-up appointments. The study included a 12-week untreated run-in phase as an integrated control, capturing the patients’ natural history and baseline parameters for evaluating treatment results. Subsequently, all patients received a 24 mg once-daily dose of OMT-28 for a treatment period of up to 24 weeks. The study ended after a subsequent four-week follow-up period. The level of GDF-15, a prospective biomarker for reflecting cellular stress and inflammation, was used as a screening and inclusion criteria, while reduction of GDF-15 was used as a primary endpoint next to demonstrating safety and tolerability in PMD patients. The study outcome did not support the choice of GDF-15 in this setting suggesting that OMT-28 is acting downstream of the release mechanism of GDF-15.

To assess clinically meaningful improvements in the study population, the PMD-OPTION study utilized a combination of objective exercise endpoints and patient-reported outcomes. Using these measures, the study demonstrated a response rate of more than 60%. In the 12-Minute Walk Test (12 MWT) and the 5x Sit-to-Stand Test (5xSST), both accepted endpoints for pivotal studies, the entire study population showed improvements over baseline, while OMT-28 responders exhibited profound and statistically significant (12 MWT) clinical improvements compared to non-responders.

These results strongly correlated with a highly significant increase in total NAD+ levels in the responder group compared to baseline, and a clear separation between responders and non-responders in NAD+/NADH ratios over the course of the study. In patients responding to OMT-28 treatment, mean NAD+ levels were approximately 30% higher compared to baseline, bringing this crucial indicator of mitochondrial energy metabolism and redox status close to healthy ranges. Similarly, OMT-28 demonstrated a significant improvement in total GSH and GSH/GSSG ratios—key indicators of reduced oxidative stress in mitochondrial diseases—thereby reestablishing normal, healthy levels and even showing a trend toward further enhancement. Together, these results demonstrate that OMT-28’s ability to normalize both NAD⁺/NADH and GSH/GSSG ratios addresses the core pathologies of PMD—energy deficiency and oxidative stress—differentiating it from single-mechanism approaches and supporting its potential as a first-in-class therapy.

About OMEICOS

OMEICOS Therapeutics has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat mitochondrial dysfunction, inflammatory, cardiovascular and other diseases. Epoxyeicosanoids activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. For more, please visit: www.omeicos.com

Contacts

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

Valency Communications
Mario Brkulj
Phone: +49 (0) 160 93529951
E-Mail: mbrkulj@valencycomms.eu

        ^{* This project receives funding from the German Federal Ministry of Education and Research under  
          the  “KMU-innovativ: Biomedizin” program}

Interim data confirms OMT-28’s strong safety profile in PMD patients, top-line data expected mid-2025

BERLIN, GERMANY, September 26, 2024 – OMEICOS, a biopharmaceutical company developing first-in-class small molecule therapeutics, today announced the completion of enrollment in its multi-center, open-label Phase 2a PMD-OPTION study of OMT-28 in Primary Mitochondrial Disease (PMD) patients suffering from myopathy and cardiomyopathy. OMEICOS expects
top-line data to become available by mid- 2025.

“Meeting our PMD-OPTION enrollment target about a year after including the first patient is a significant milestone for the OMT-28 development program. We are very grateful for the commitment by patients and investigators for our study,” said Dr. Robert Fischer, CEO/CSO of OMEICOS Therapeutics. “Initial data analysis confirms the strong safety profile and very good tolerability of OMT-28 in the target population. Furthermore, the clinical data obtained so far looks promising for relevant endpoints, which bodes well for our goal to provide a much-needed new treatment option for patients underserved by current therapies.”

The primary endpoints of the PMD-OPTION study are safety and tolerability of OMT-28 and the response rate of patients showing a reduction of Growth differentiation factor 15 (GDF-15) levels by at least 20% compared to baseline. GDF-15, which is produced in response to mitochondrial stress, inflammation or hypoxia, is emerging as a strong risk predictor in many diseases including cardiometabolic and PMD. The study also evaluates a range of secondary and exploratory endpoints to determine the effect of OMT-28 on relevant clinical symptoms, standard functional parameters of physical strength, heart function, quality of life, and key metabolic biomarkers.

PMD patients suffer from debilitating and life-threatening health consequences, such as severely limited physical stamina and disease-related changes in the heart and skeletal muscles, as well as associated neurological disorders. OMEICOS’ therapeutic strategy with OMT-28 could translate into improved cell metabolism and mitochondrial function, which in turn would bring significant quality of life benefits to PMD patients and their families. The PMD-OPTION study has enrolled a total of 28 PMD patients and features a 12-week untreated run-in phase, capturing the patients’ natural history and baseline parameters. Subsequently, all patients receive a 24 mg once-daily dose of OMT-28 for a treatment period of up to 24 weeks.

About OMT-28

OMT-28 is a first-in-class small molecule that has demonstrated cell protective, anti-inflammatory and anti-atherosclerotic properties. OMEICOS has generated comprehensive preclinical and clinical datasets demonstrating the compounds strong safety profile and tolerability as well as its therapeutic potential in cardiovascular diseases targeting inflammation in atherosclerosis and cardiomyopathy, as well as other age-related diseases including AMD. In the active PMD-OTION Phase 2 clinical study, OMEICOS is evaluating OMT-28 in Primary Mitochondrial Disease patients.

Contacts

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

Valency Communications
Mario Brkulj
Phone: +49 (0) 160 93529951
E-Mail: mbrkulj@valencycomms.eu

        ^{* This project receives funding from the German Federal Ministry of Education and Research under  
          the  “KMU-innovativ: Biomedizin” program}

BERLIN, GERMANY, September 18, 2023 – OMEICOS, a biopharmaceutical company developing first-in-class small molecule therapeutics based on the profound understanding of omega-3 fatty acid metabolism and physiology, today provided a positive update on the Company’s multi-center, open-label Phase 2a clinical study evaluating its most advanced development program OMT-28 in Primary Mitochondrial Disease (PMD) patients. The PMD-OPTION study, which has begun to enroll patients in the first observational part of the trial, will evaluate safety, tolerability, pharmacodynamics, and signs of efficacy of OMT-28 in PMD patients with myopathy and/or cardiomyopathy and inflammation.

“We are thrilled to announce that the first patients are being enrolled in the study at clinical centers in Italy and Germany. We thank all involved investigators supporting us in our ambitious way forward to bring a novel, first-in-class therapeutic strategy closer to the PMD patient community,” commented Dr. Robert Fischer, CEO/CSO of OMEICOS Therapeutics. “The start of the PMD-OPTION study marks a major milestone in OMEICOS’ strategy to tackle diseases associated with impaired function of the mitochondria. OMT-28 has shown the potential to target a key regulator network for cell metabolism and mitochondrial function, which could translate into benefits for PMD patients and improve their quality of life.”

PMD patients suffer from debilitating and life-threatening health consequences, such as severely limited physical stamina and disease-related changes in the heart and skeletal muscles, as well as associated neurological disorders. In preclinical in vitro and in vivo tests, the positive influence of OMT-28 on mitochondrial function and its impact on inflammatory processes associated with the condition has been demonstrated.

The PMD-OPTION study will recruit up to 32 patients with documented mutations in either mitochondrial tRNA, e.g. MELAS and MERFF mutations, or mtDNA resulting in mitochondrial disease and are suffering from myopathy (muscle weakness and/or exercise intolerance) and/or cardiomyopathy (heart disease). The study design features a 12-week untreated run-in phase, capturing the patients’ natural history and baseline parameters. Subsequently, all patients will receive a 24 mg once-daily dose of OMT-28 for a treatment period of up to 24 weeks. The primary endpoints of the PMD-OPTION study are safety and tolerability of OMT-28, and the response rate of patients showing a reduction of Growth differentiation factor 15 (GDF-15) levels by at least 20% compared to the recorded baseline. The cytokine GDF-15 is produced in response to mitochondrial stress, tissue damage or hypoxia, and is emerging as a key biomarker to detect mitochondrial myopathies and distinguish such cases from other myopathies, including metabolic myopathies. The study will also evaluate a range 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.

More information on the PMD-OPTION study can be found on ClinicalTrials.gov.

About OMEICOS

OMEICOS Therapeutics has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat mitochondrial dysfunction, inflammatory, cardiovascular and other diseases. Epoxyeicosanoids activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. For more, please visit: www.omeicos.com

Contacts

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

Valency Communications
Mario Brkulj
Phone: +49 (0) 160 93529951
E-Mail: mbrkulj@valencycomms.eu

        ^{* This project receives funding from the German Federal Ministry of Education and Research under  
          the  “KMU-innovativ: Biomedizin” program}

BERLIN, GERMANY, June 21, 2023 – OMEICOS, a biopharmaceutical company developing first-in-class small molecule therapeutics based on the profound understanding of omega-3 fatty acid metabolism and physiology, announced today that the Company has received a significant grant by the German Federal Ministry of Education and Research (“BMBF”) strongly supporting the development of OMEICOS’ lead product candidate OMT-28^*. The funding provided under the “KMU-innovativ: Biomedizin” program will be used to co-finance the upcoming Phase 2a clinical study evaluating OMT-28 in Primary Mitochondrial Disease (PMD) patients. The study will be conducted in leading European clinical centers for mitochondria-related pathologies. In April 2023, OMEICOS had received first approvals of the study design from the respective regulatory authorities.

“Securing the funding to complement our own investment in the upcoming Phase 2a is a major achievement for the team and will boost our ability to demonstrate OMT-28’s potential in PMD. Beyond the strong financial support, the BMBF’s decision adds further validation to our approach of expanding the clinical development of OMT-28 into this indication,” commented Dr. Robert Fischer, CEO/CSO of OMEICOS Therapeutics. “We are on track with our first clinical study in PMD, which will allow us to generate meaningful safety data and show the drug’s impact on a set of clinically relevant parameters. As a rare disease with no or only insufficient treatment options available, bringing innovation and novel therapeutic concepts to PMD patients and their families quickly is crucial.”

PMD patients suffer from debilitating and life-threatening health consequences, such as severely limited physical stamina and disease-related changes in the heart and skeletal muscles, as well as associated neurological disorders. In preclinical in vitro and in vivo tests, the positive influence of OMT-28 on mitochondrial function and its impact on inflammatory processes associated with the condition has been demonstrated. As part of OMEICOS development activities in cardiovascular diseases, OMT-28 had previously shown an excellent safety profile in two clinical trials and 162 individuals in total. Profound effects on key biomarkers of metabolic and inflammatory stress such as GDF-15, IL-6, PTX-3 and hs-CRP observed in these studies provide a very promising scientific rationale for the translation of the therapeutic concept into mitochondrial health.

About OMEICOS

OMEICOS Therapeutics has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat mitochondrial dysfunction, inflammatory, cardiovascular and other diseases. Epoxyeicosanoids activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. For more, please visit: www.omeicos.com

Contacts

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

Valency Communications
Mario Brkulj
Phone: +49 (0) 160 93529951
E-Mail: mbrkulj@valencycomms.eu

        ^{* This project receives funding from the German Federal Ministry of Education and Research under  
          the  “KMU-innovativ: Biomedizin” program}