OPM Reports Final Results of Its Phase 1 Study With RIPK2 Inhibitor OPM-101, With Strong Safety Data and No Cardiac Toxicity, Paving the Way for the Launch of Phase 1b/2a

In This Article:

  • Finalization of the study report on the double-blind, placebo-controlled Phase 1 trial of OPM-101 in 104 healthy volunteers (HV) who received OPM-101

  • 24-hour ECG analysis reveals no toxic effect of OPM-101 on cardiac parameters

  • In an ex vivo whole blood study, OPM-101 rapidly and completely inhibited the stimulated release of TNFα, a downstream marker of RIPK2 pathway activation, indicating a strong pharmacological immunomodulatory effect

  • PK/PD modeling predicts that a concentration of OPM-101 between 100 and 300 ng/mL would achieve target inhibition of at least 80% over the entire treatment period

  • The favorable safety, pharmacokinetics and pharmacodynamics of OPM-101 support the pursuit of its clinical development for the treatment of diseases caused by deregulation of the pathway involving its therapeutic target, the RIPK2 kinase

  • Phase 1b/2a clinical trial protocol to be filed in the fourth quarter of 2024 for launch in early 2025

DIJON, France, October 22, 2024--(BUSINESS WIRE)--Regulatory News:

Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Mnemonic: ALOPM), a biopharmaceutical company specializing in precision medicine for the treatment of resistant and metastatic cancers, today confirms and details the final results of its Phase 1 clinical trial with OPM-101, its RIPK2 inhibitor and drug candidate administered orally to healthy volunteers, first reported on July 16, 2024. This clinical trial began in February 2023, the database was frozen in June 2024, and the full results and final study report became available, as scheduled in the study timetable, in October 2024.

OPM-101 is an experimental, powerful and selective small molecule inhibitor of the RIPK2 kinase. OPM-101 is designed to modulate the pro-inflammatory signal transmission pathway of this kinase, which is responsible for the development of inflammatory diseases, and has the potential to treat diseases in the fields of IBD (Chronic Inflammatory Bowel Disease) and immuno-oncology.

This randomized, double-blind, placebo-controlled phase 1 study was designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OPM-101 (EudraCT: 2022-003122-50) in 104 healthy volunteers:

- In the SAD part of the trial, 72 HV (mean age = 34 years) received a single oral dose of placebo or 5, 20, 60, 150, 300, 600 or 1,000 mg of OPM-101, with one cohort dedicated to the high-fat meal effect and another to the gender effect, also receiving 150mg.

- In the MAD part of the trial, 32 HV (mean age = 36 years) received an oral dose of 75, 150 or 300 mg of OPM-101 or placebo twice daily for 14 consecutive days, including a cohort dedicated to the gender effect, receiving 150mg twice a day.