Oncodesign Precision Medicine (OPM) has announced positive results from a Phase 1 trial evaluating OPM-101, a selective small molecule inhibitor targeting the RIPK2 kinase. The trial assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of OPM-101 in healthy volunteers.
The randomized, double-blind, placebo-controlled study (EudraCT: 2022-003122-50) enrolled 104 volunteers, 78 treated with OPM-101, and 26 received placebo. OPM-101 was administered orally in single ascending doses (SAD) and multiple ascending doses (MAD).
Key findings include:
• OPM-101 was well-tolerated and significantly inhibited the RIPK2 pathway at low doses (60 mg single administration and 75 mg twice daily in MAD).
• Target engagement was observed within 2 to 4 hours after the first administration, sustaining inhibition for 14 days.
• MAD administrations demonstrated maximum target engagement, leading to a 90-100% reduction in TNFα production. This immunomodulatory effect was observed without total suppression of immunity.
The results suggest that OPM-101 can potentially treat inflammatory diseases like IBD (Chronic Inflammatory Bowel Disease) and immuno-oncology. OPM is currently investigating OPM-101’s efficacy in multiple clinical trials for various inflammatory diseases.
The RIPK2 kinase is crucial in regulating immune responses and inflammatory processes, making it a promising therapeutic target. OPM-101’s ability to selectively inhibit RIPK2 and modulate pro-inflammatory signaling pathways highlights its potential for treating various immune-related conditions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
