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Forward Therapeutics Announces Completion of Phase 1 Trials with Two Internally Discovered Next-Generation TNF Signaling Inhibitors Supporting Advancement to Phase 2 Clinical Development
PALM BEACH GARDENS, Fla., May 14, 2026 (GLOBE NEWSWIRE) -- Forward Therapeutics, Inc (“Forward” or “the Company”), a clinical-stage biotechnology company developing oral small molecule therapies for inflammation-driven diseases, today announced the successful completion of Phase 1 first-in-human trials for two internally-discovered drug candidates, FT2109 and FT751, and the selection of FT2109 as its lead candidate for advancement into Phase 2 development.
FT2109 is an investigational oral TNF signaling inhibitor (TNFsi) designed to selectively target soluble TNF while sparing membrane TNF signaling, with the goal of improving safety and therapeutic activity across a range of inflammation-driven diseases. Unlike anti-TNF biologics, which broadly block TNF signaling, FT2109 is designed to target pathological inflammation while preserving regulatory and host defense functions.
“Selective TNF signaling inhibition represents a promising therapeutic approach with potential applicability across multiple inflammation-driven diseases. Forward Therapeutics has evaluated two TNF signaling oral inhibitors, FT751 and FT2109, both of which have demonstrated promising safety and pharmacologic profiles in two separate Phase 1 trials. Based on a comprehensive assessment of data from the Phase 1 programs for both candidates, we selected FT2109 as our lead candidate for further development given its overall, potentially best-in-class profile, and are excited to advance it into a Phase 2 trial,” commented Toufike Kanouni, Chief Executive Officer of Forward Therapeutics.
Data from the Phase 1 FT2109 program are expected to be submitted for presentation at a future scientific meeting.
About FT2109
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.
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.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the initiation, timing, and conduct of clinical trials, the development and potential therapeutic profile of FT2109 and other investigational therapies, and Forward Therapeutics’ plans, objectives, and expected milestones. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include, but are not limited to, risks related to regulatory review and approval processes, the design, initiation, execution, and outcomes of clinical trials, the ability to generate and interpret clinical data, and other factors beyond the Company’s control. Forward Therapeutics undertakes no obligation to update these forward-looking statements except as required by law.
Company Contact
Clement Pimor
SVP, Corporate Development
Email: clement@forward-tx.com
Media Contact
Email: media@forward-tx.com
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