Oncodesign Precision Medicine (OPM) has announced the successful completion of its Phase 1 clinical trial for OPM-101, an orally administered RIPK2 inhibitor. The trial began in February 2023 and concluded in October 2024 and involved 104 healthy volunteers.
The study was divided into two parts: single ascending dose (SAD) and multiple ascending dose (MAD). In the SAD portion, participants received a single dose of OPM-101 ranging from 5mg to 1000mg or a placebo. The MAD portion saw participants receiving 75mg, 150mg, or 300mg of OPM-101, or a placebo, twice daily for 14 days.
OPM-101 demonstrated excellent safety and tolerability profiles throughout the trial. No serious adverse events were reported, and no participant withdrew due to adverse effects. The few reported adverse events were generally mild and transient, primarily headaches.
Significantly, OPM-101 showed promising results in inhibiting the RIPK2 pathway, a key target for treating inflammatory diseases and certain cancers. The inhibitory effect was rapid and sustained, reaching a maximum of 90-100% within hours of administration and persisting for the treatment period.
Pharmacokinetic analysis revealed that OPM-101 is quickly absorbed, reaching peak concentration within 2-4 hours, and has a half-life of approximately 12 hours. These characteristics make it suitable for patient use. Researchers believe a twice-daily dose of 150mg could achieve optimal therapeutic levels based on the trial data.
Encouraged by these positive results, OPM plans to submit a protocol for a Phase 1b/2a clinical trial in the fourth quarter of 2024. This next phase will evaluate OPM-101’s efficacy in patients with specific inflammatory diseases or cancers.
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.
