Forward Therapeutics Announces First Participants Dosed in Phase 1 Healthy Volunteer Study of FT2109, a Next-Generation TNF Signaling Inhibitor
PALM BEACH GARDENS, Fla., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Forward Therapeutics, Inc (“Forward”), a biotechnology company developing oral small molecule therapies for inflammation-driven diseases, today announced that the first participants have been dosed in its Phase 1 healthy volunteer trial evaluating FT2109, the company’s second TNF signaling inhibitor in development for chronic inflammatory diseases.
FT2109 is a next-generation oral small molecule designed to inhibit TNFR1 signaling by binding to soluble TNF (sTNF), a primary driver of chronic inflammatory diseases. While injectable anti-TNF biologics have revolutionized the treatment of inflammatory diseases and improved outcomes for millions of patients, important limitations remain, including the need for injections, elevated risk of infections and demyelinating events, paradoxical inflammatory responses, and the formation of anti-drug antibodies that can diminish efficacy over time. FT2109 is designed to overcome these challenges by improving efficacy, safety, adherence, and durability. FT2109 follows the company’s lead asset, FT751, a TNF signaling inhibitor also in Phase 1 clinical development.
Toufike Kanouni, Co-Founder and Chief Executive Officer of Forward Therapeutics, commented, “Forward is building a portfolio of potentially best-in-class oral TNF signaling inhibitors grounded in pharmacologic precision and long-term safety. With FT2109 now in the clinic alongside FT751, we’re executing on that vision, advancing small molecules designed to selectively and predictably modulate inflammation. As external validation builds for this class, we believe that with the right chemistry, differentiated PK and safety profiles, oral TNF inhibition can deliver meaningful and durable therapeutic impact.”
The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study evaluating single and multiple ascending doses of FT2109 in healthy adult volunteers. The trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of FT2109, as well as food effect and elderly PK.
Unlike anti-TNF biologics, which broadly block all TNF signaling, FT751 and FT2109 are engineered to selectively inhibit sTNF-TNFR1 signaling. This targeted approach is designed to efficiently target pathological inflammation, while preserving membrane TNF driven regulatory and host defense mechanisms. In preclinical studies, both FT2109 and FT751 demonstrated potent anti-inflammatory activity, promising oral bioavailability, and a favorable safety profile, with advantages in tolerability and dosing flexibility.
About Forward Therapeutics
Forward Therapeutics is a clinical-stage biopharmaceutical company advancing a pipeline of internally-discovered novel, oral small molecule therapies for inflammation-driven diseases. The company builds its portfolio using SWIFT™, a data-driven drug discovery engine designed to unlock high-potential, hard-to-drug targets, an approach that combines curated, drug-like libraries with elaborated screening assays and deep structural insights to enable rapid hit finding and lead optimization. For more information, visit www.forward-tx.com and follow us on LinkedIn.
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Email: clement@forward-tx.com
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