OMT-28 / OMEICOS - LARVOL DELTA

OMT-28 in Patients With Primary Mitochondrial Disease (PMD) (PMD-OPTION) (clinicaltrials.gov) - P2 | N=28 | Completed | Sponsor: Omeicos Therapeutics GmbH | Active, not recruiting ➔ Completed

Trial completion • Cardiomyopathy • Cardiovascular • Inflammation • Metabolic Disorders • Myositis • GDF15

OMT-28, a synthetic analog of 17,18-epoxyeicosatetraenoic acid, mitigates lipopolysaccharide-induced lung injury in mice. (PubMed, Eur J Pharmacol) - "SIRT3 silencing abolished the anti-inflammatory and epithelial cell integrity effects of OMT-28 in BEAS-2B cells and A549 cells. Overall, these findings indicate that OMT-28 may protect against LPS-induced lung injury by maintaining SIRT3 expression and mitochondrial function."

Journal • Preclinical • Acute Respiratory Distress Syndrome • Inflammation • Metabolic Disorders • Pneumonia • Pulmonary Disease • Respiratory Diseases • CCL2 • CXCL8 • IL1B • IL6 • SIRT3 • TJP1 • TNFA

OMT-28 in Patients With Primary Mitochondrial Disease (PMD) (PMD-OPTION) (clinicaltrials.gov) - P2 | N=32 | Active, not recruiting | Sponsor: Omeicos Therapeutics GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiomyopathy • Cardiovascular • Inflammation • Metabolic Disorders • Myositis • GDF15

Cardioprotective properties of OMT-28, a synthetic analog of omega-3 epoxyeicosanoids. (PubMed, J Biol Chem) - "Furthermore, OMT-28 (1 μM) limited IR-induced NLRP3 inflammasome activation similarly like a direct NLRP3 inhibitor (MCC950). Overall, this study demonstrates that OMT-28 possesses potent cardio-protective and anti-inflammatory properties supporting the hypothesis that extending the bioavailability of omega-3 epoxyeicosanoids may improve their prospects as therapeutic agents."

Journal • Cardiovascular • Reperfusion Injury • NLRP3 • PPARA • SIRT1 • TNFA

OMT-28 in Patients With Primary Mitochondrial Disease (PMD) (PMD-OPTION) (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Omeicos Therapeutics GmbH | Phase classification: P2a ➔ P2

Phase classification • Cardiomyopathy • Cardiovascular • Inflammation • Metabolic Disorders • Myositis • GDF15

OMT-28 in Patients With Primary Mitochondrial Disease (PMD) (PMD-OPTION) (clinicaltrials.gov) - P2a | N=32 | Recruiting | Sponsor: Omeicos Therapeutics GmbH | Trial completion date: Sep 2024 ➔ Jun 2025 | Trial primary completion date: Jul 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Cardiomyopathy • Cardiovascular • Inflammation • Metabolic Disorders • Myositis • GDF15

OMT-28 in Patients With Primary Mitochondrial Disease (PMD) (PMD-OPTION) (clinicaltrials.gov) - P2a | N=32 | Recruiting | Sponsor: Omeicos Therapeutics GmbH | N=16 ➔ 32

Enrollment change • Cardiomyopathy • Cardiovascular • Inflammation • Metabolic Disorders • Myositis • GDF15

OMT-28 in Patients With Primary Mitochondrial Disease (PMD) (PMD-OPTION) (clinicaltrials.gov) - P2a | N=16 | Recruiting | Sponsor: Omeicos Therapeutics GmbH

New P2a trial • Cardiomyopathy • Cardiovascular • Inflammation • Metabolic Disorders • Myositis • GDF15

A clinical study of a new drug (OMT-28) for use in patients suffering from the genetic disease PMD including muscle disease and/or Heart muscle disease and inflammation (PMD-OPTION) Eine klinische Studie mit einem neuen Medikament (OMT-28) zurAnwendung bei Patienten, die unter der genetischen Erkrankung PMDleiden, zusammen mit Muskelerkrankung und/oder Herzmuskelerkrankungund Entzündung... (clinicaltrialsregister.eu) - P2 | N=22 | Ongoing | Sponsor: OMEICOS Therapeutics GmbH

New P2 trial • Cardiomyopathy • Cardiovascular • Genetic Disorders • Inflammation • Metabolic Disorders • Myositis • GDF15

PROMISE-AF: Study on OMT-28 in Maintenance of Sinus Rhythm in Patients With Persistent Atrial Fibrillation (AF) (clinicaltrials.gov) - P2; N=136; Completed; Sponsor: Omeicos Therapeutics GmbH; Recruiting ➔ Completed

Clinical • Trial completion • Atrial Fibrillation • Cardiovascular

Assessment of OMT-28, a synthetic analog of omega-3 epoxyeicosanoids, in patients with persistent atrial fibrillation: Rationale and design of the PROMISE-AF phase II study. (PubMed, Int J Cardiol Heart Vasc) - P2 | "The primary efficacy analysis will be conducted on the modified intention-to-treat (mITT) population, whereas the safety analysis will be done on the safety population. Although ICMs have been used in other interventional studies to assess arrhythmia, PROMISE-AF will be the first study to assess antiarrhythmic efficacy and safety of a novel rhythm-stabilizing drug after DCC by using ICMs."

Clinical • Journal • P2 data • Atrial Fibrillation • Cardiovascular