COL-5671 / Coultreon Biopharma - LARVOL DELTA

SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS FROM A PHASE 1A STUDY OF COL-5671, A FIRST-IN-CLASS SIK3 INHIBITOR THAT SUPPRESSES TNFΑ, IL-23 AND IL-12 (UEGW 2026) - No abstract available

Clinical • P1 data • PK/PD data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • IL12A • IL23A • TNFA

Coultreon Biopharma Raises $125 Million in Series A Financing to Advance Immunology Pipeline (GlobeNewswire) - "The financing will support the further clinical development of Coultreon’s lead immunology program, COL-5671 (formerly O3R-5671), a highly selective, oral once-daily SIK3 inhibitor currently in Phase 1 studies. The company plans to advance COL-5671 into psoriasis and ulcerative colitis Phase 2 clinical trials, with potential to demonstrate clinical proof-of-concept in 2027."

Financing • New P2 trial • Psoriasis • Ulcerative Colitis

The First-in-Class SIK3 Inhibitor O3R-5671 Demonstrates Optimal Pharmacokinetics and Potent and Sustained Pharmacodynamic Activity in Human Participants (ECCO-IBD 2026) - "Full PK and cytokine analyses from all available SAD and MAD cohorts will be presented. As O3R-5671 is expected to strongly inhibit IL-23 and IL-12 on top of TNFα, a high response rate is expected in IBD patients."

PK/PD data • Inflammatory Bowel Disease • Ulcerative Colitis • AMPK • IL12A • IL23A • SIK1

O3R-5671 Pharmacokinetic and Pharmacodynamic Data to be Presented at ECCO and Dosing in Final Cohort in First-in-human study initiated (GlobeNewswire) - "The pharmacokinetic (PK) data generated in the first-in-human study demonstrates a highly attractive PK profile with a long half-life, low interpatient variability and highly correlative dose-exposure relationship. Pharmacodynamic (PD) data on O3R-5671’s ability to inhibit TNFα release in the blood of dosed participants indicate that it is a highly potent inhibitor with the ability to inhibit TNFα as efficiently as monoclonal antibodies. Data from the 15mg MAD cohort demonstrate that O3R-5671 is able to potently inhibit TNFα in a sustained manner....Studies in ulcerative colitis and psoriasis to initiate in H2 2026."

First-in-human • New trial • PK/PD data • Trial status • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis