Leuven, Belgium — September 4, 2025 — Leads & Copy — Onco3R Therapeutics, a clinical-stage immunology and oncology biotech company, announced the approval of a Clinical Trial Application (CTA) by Belgian regulatory authorities for its SIK3 inhibitor O3R-5671. The trial will be conducted at the SGS Clinical Pharmacology Unit in Antwerp.
The first-in-human trial will evaluate O3R-5671 in healthy volunteers using a single ascending dose (SAD) and multiple ascending dose (MAD) design. The trial includes extensive biomarker tests that will provide insights into how O3R-5671 modulates immune responses. Patient trials across a range of autoimmune diseases are planned to commence in 2026.
O3R-5671 has been developed based on more than 12 years of preclinical and clinical data on SIK inhibitors for autoimmune diseases, and is expected to have applications across a broad range of conditions, including ulcerative colitis, Crohn’s disease, psoriasis, psoriatic arthritis, and rheumatoid arthritis.
Pierre Raboisson, PhD, CEO and Founder of Onco3R Therapeutics, said the company is dedicated to improving patients’ lives through best-in-class medicines and by building a deep pipeline in immunology and oncology. He added that the company is uniquely positioned to develop a well-tolerated, effective, and convenient oral therapy for patients with autoimmune diseases.
The first-in-human trial is expected to start enrolling subjects over the coming weeks, with dosing of the first subject anticipated later in September. Final data from the study are expected to be available in the first half of 2026.
Contact: contact@onco3r.com
Source: Onco3R Therapeutics
