OMEICOS Therapeutics Provides Update on PMD-OPTION Phase 2a Clinical Study Evaluating OMT-28 in Primary Mitochondrial Disease

Berlin, Germany, September 18, 2023

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.”

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}

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OMEICOS Therapeutics Receives 2.5 million Euros in Grant Funding Supporting OMT-28’s Development in Mitochondrial Diseases Through a Phase 2a Clinical Study

Berlin, Germany, June 21, 2023

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

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}

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OMEICOS Therapeutics Announces Expansion of OMT-28 Clinical Development Program into Primary Mitochondrial Diseases

Berlin, Germany, December 08, 2022

OMT-28’s established safety profile, biomarker data, and funding secured from existing investors enable swift transition into a Phase II clinical study

BERLIN, GERMANY, December 08, 2022 – OMEICOS, a biopharmaceutical company developing first-in-class small molecule therapeutics based on the reimagining of omega-3 fatty acid metabolism and physiology, announced the closing of a new financing round and the expansion of its clinical development activities into an indication with high unmet medical need – Primary Mitochondrial Disease (PMD). The financing, led by Remiges Ventures, Vesalius Biocapital and SMS group GmbH, will allow OMEICOS to advance its lead program, OMT-28, into a first Phase II study in PMD patients in H1 2023. OMT-28 had shown an excellent safety profile in two clinical trials and 162 individuals in total and profound effects on key biomarkers of metabolic and inflammatory stress such as GDF-15, IL-6, PTX-3 and hs-CRP.

“The expansion of OMT-28’s clinical development program into PMD will allow us to gain further evidence on the compound’s capability to target mitochondrial dysfunction and associated inflammation as well as to obtain first clinical response data from this group of severely affected patients that still have very limited treatment options”, commented Dr. Robert Fischer, CEO/CSO of OMEICOS Therapeutics. “With the initiation of the upcoming Phase II study in PMD, OMEICOS is immediately positioned as a clinical-stage developer in an attractive rare disease market with a significant unmet medical need. In this indication, OMEICOS benefits from the unique blend of expertise in cardiology and muscle cell physiology combined with the profound understanding of the multimodal effects of our molecules in metabolic and inflammatory stress pathways.”

Defects of the mitochondrial oxidative phosphorylation system (OXPHOS) results in oxidative and reductive stress and chronic activation of pro-inflammatory pathways, leading to disease progression and ultimately reduced life expectancy in many indications, including PMD. While PMD’s are a highly heterogeneous group of diseases, high energy requiring tissue and organs are most affected and as a consequence, myopathies and cardiomyopathies represent two of the key hallmarks in several PMD patient populations.

About OMEICOS

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

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OMEICOS Therapeutics Announces First-Dosing in Phase 2 Clinical Study Evaluating its Lead Program OMT-28 in Patients with Persistent Atrial Fibrillation

Berlin, Germany, April 29, 2019

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.

About OMEICOS

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

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

MacDougall Biomedical Communications
Mario Brkulj or Kara Mazey
Phone: +49 89 2424 3494 or +1 781-235-3060
E-Mail: omeicos@macbiocom.com

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OMEICOS Therapeutics Closes €17m Series C Financing to Advance Lead Candidate OMT-28 Towards Pivotal Trials in Atrial Fibrillation

Berlin, Germany, and Boston, MA, USA, November 2, 2018

Proceeds provide OMEICOS with the financial runway to conduct the Phase II Study PROMISE-AF and continue expansion into ophthalmology through US subsidiary

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 closing of a EUR 17 million (approx. USD 19.5 million) Series C financing led by new investor Forbion.

Existing investors Vesalius Biocapital II S.A. SICAR, Remiges BioPharma Fund, SMS Group GmbH, KFW Group, VC Fonds Technologie Berlin, High-Tech Gründerfonds II GmbH & Co. KG and The Falck Revocable Trust participated as well. The proceeds from this round will finance PROMISE-AF, a placebo controlled, double-blinded, randomized, dose finding Phase II study on OMT-28 in maintenance of sinus rhythm after electrical cardioversion in patients with persistent atrial fibrillation. Additionally, OMEICOS will continue to drive the expansion of its pipeline into novel indications including ophthalmology, led by its US-based subsidiary OMEICOS Ophthalmics. “This financing arrives in a particularly exciting time for the OMEICOS team as we accelerate plans to initiate our Phase II study of OMT-28, OMEICOS’ novel safe rhythm stabilizer developed for patients with atrial fibrillation. The investment of Forbion confirms the excellent work of the entire team and supports our ambitious plans in atrial fibrillation and other indications,” commented Robert Fischer, MD, CEO/CSO of OMEICOS Therapeutics. Holger Reithinger, Ph.D. General Partner at Forbion added: “We’ve been following the OMEICOS story for some time and are very positive about the progress. The unique concept of a novel treatment for atrial fibrillation together with the excellent safety data of OMT-28 convinced us to invest and support the future growth of the company.” Christian Schneider, Ph.D. Managing Partner at Vesalius Biocapital commented: “The addition of Forbion is another consequent step in the successful development of OMEICOS. The shareholders highly welcome Forbion’s commitment to join forces in order to accelerate the company’s development pipeline in indications with high unmet medical need.” OMEICOS is developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular and ophthalmic diseases. The compounds are synthetic analogs of naturally occurring, but metabolically unstable, metabolites of omega-3 fatty acids that can activate anti-arrhythmic, cardio protective and anti-inflammatory pathways. OMEICOS’ first-in-class small molecules can be administered orally and have shown improved biological activity and pharmacokinetic properties compared to their natural counterparts. Atrial fibrillation is the most common type of heart arrhythmia affecting an estimated 33.5 million people worldwide. Incidence is expected to increase over the next decade as life expectancy increases. The disease is associated with significant health risks and current therapies have limited efficacy and safety. OMEICOS Ophthalmics was established in Boston, MA, USA in August 2017 to focus on a clinical development program for OMEICOS’ ophthalmological drug indications. OMEICOS’ compounds are currently in preclinical development for macular edema disease, including wet age-related macular degeneration (AMD) and diabetic retinopathy. New treatments for wet AMD are needed to reduce the burden of repeated, frequent injections of therapeutics into the eye, and to offer more convenient routes of administration.

Meet OMEICOS Therapeutics at BIO-Europe 2018 in Copenhagen: Dr. Robert Fischer, CEO of OMEICOS will give a company presentation on Tuesday, November 6th, 4:45 pm, Cardiovascular track, Room B1

About OMEICOS

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, 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. 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 are supported by a grant from the German Ministry of Education and Research (BMBF). 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

MacDougall Biomedical Communications
Mario Brkulj or Kara Mazey
Main: +49 89 2424 3494 or +1 781-235-3060
E-Mail: omeicos@macbiocom.com

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OMEICOS Therapeutics Announces Compelling First-in-Human Data on Lead Compound OMT-28 and Prepares Phase 2 Trial in Atrial Fibrillation

Berlin, Germany, July,17 2018

High-resolution electrocardiography strongly supports OMT-28’s claim for low pro-arrhythmic risk

The study met its primary goal with OMT-28 exhibiting an excellent tolerability profile and showing no safety signals in vital signs or safety laboratory parameters up to the maximum dose tested, which was 60 mg. High-resolution electrocardiography recordings were used to detect any heart beat anomalies such as QT-prolongations and changes in the PR and QRS intervals. OMT-28 did not have a clinically relevant effect on these heart rate parameters or on cardiac conduction at all doses tested in the trial which strongly supports OMT-28’s claim to have a low risk for pro-arrhythmia. With the Phase 1 trial concluded, OMEICOS has accelerated its plans to initiate a subsequent Phase 2 trial focused on maintenance of sinus rhythm in patients suffering from non-permanent Atrial Fibrillation. “It is very encouraging to see that even at the highest dose tested for OMT-28, the regular heart beat physiology in healthy volunteers remained intact, since the tendency of existing antiarrhythmic drugs to lead to the emergence of potentially life threatening arrhythmias is a well-documented paradox”, said Robert Fischer, MD, CEO of OMEICOS Therapeutics. “We believe this further supports our claim that OMT-28 could become the first example of a complete novel class of drugs combining anti-arrhythmic, cardioprotective and anti-remodelling effects for long-term rhythm maintenance. With this data, the swift execution of our development plan for OMT-28 remains a top priority for OMEICOS and we are eager to initiate the subsequent Phase 2 trial in patients suffering from a common form of atrial fibrillation. Additionally, the results of our first-in-human study put us in a great position to unlock the tremendous potential of OMT-28 and the entire new molecule class in several other indications”. OMEICOS’ lead compound, 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. OMT-28 has already proven its anti-arrhythmic, cardioprotective and anti-fibrotic potential in different in vivo models. The now concluded randomized, double-blind, placebo-controlled Phase 1 study was conducted at two centers in Germany and enrolled 75 subjects. The results of the first-in-human trial demonstrate that OMT-28’s pharmacokinetic profile allows a once daily oral treatment. Additional parameters analyzed in the trial were the impact of the subject’s gender or diet on the uptake and metabolism of OMT-28.

For more information on the trial (NCT03078738) please visit https://clinicaltrials.gov.

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

MacDougall Biomedical Communications
Mario Brkulj or Kara Mazey
Main: +49 89 2424 3494 or +1 781-235-3060
E-Mail: omeicos@macbiocom.com