FT2109 / Forward Therap - LARVOL DELTA

First[JR1.1]-in-Human Single and Multiple Ascending Dose Study of FT2109, a Selective Oral TNFR1 Signaling Inhibitor, in Healthy Participants (ACR Convergence 2026) - "FT2109, a novel, potential best in class oral selective TNFR1 signaling inhibitor, was safe and well tolerated in healthy participants following single and multiple ascending doses. FT2109 demonstrated dose-proportional PK properties across the evaluated dose ranges of 2-100 mg QD in SAD and 15-80 mg QD for 10 days in MAD, consistent with once-daily oral administration. These findings support continued clinical development of FT2109 for the treatment of inflammatory diseases including RA."

Clinical • Hematological Disorders • Immunology • Rheumatoid Arthritis • Rheumatology • TNFRSF1A

Discovery and Preclinical Characterization of FT2109, a Differentiated Oral TNFR1 Signaling Inhibitor (ACR Convergence 2026) - "Unlike adalimumab, FT2109 retained activity in the presence of adalimumab anti-drug antibodies...In the LPS cytokine release model and collagen-induced arthritis model, FT2109 reduced cytokine release and preserved joint integrity respectively, demonstrating efficacy comparable to the mouse cross-reactive biologic, etanercept... FT2109 demonstrated a profile distinct from TNF biologics and other oral TNF inhibitors in development. FT2109 inhibited pathogenic sTNF/TNFR1 signaling and provided anti-inflammatory efficacy comparable to biologic TNF inhibitors. FT2109 was highly selective and maintained activity in the presence of anti-drug antibodies, and preserved host-defense responses in a Listeria challenge model."

Preclinical • Immunology • Infectious Disease • TNFRSF1A

Phase 2 Trial of FT2109 for the Treatment of Psoriatic Arthritis (clinicaltrials.gov) - P2 | N=210 | Not yet recruiting | Sponsor: Forward Therapeutics

New P2 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP • IL17A