Forward Therapeutics Announces Positive Phase 1 Data for Potential Best-in-Class Oral TNFR1 Signaling Inhibitor FT2109, Supporting Advancement into Phase 2 Development
BOSTON, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Forward Therapeutics, Inc. (“Forward” or the “Company”), a clinical-stage
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BOSTON, Oct. 05, 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 positive Phase 1 clinical and preclinical data for FT2109, its novel, potential best-in-class oral selective TNFR1 signaling inhibitor. The data are included in two abstracts accepted for presentation at the American College of Rheumatology (ACR) Convergence 2026, taking place November 6–11 in Orlando, Florida.
In a randomized, double-blind, placebo-controlled Phase 1 study in healthy participants, FT2109 showed favorable safety and tolerability across the evaluated single and multiple ascending dose ranges. The overall incidence of adverse events was low and comparable to placebo, with no serious adverse events, deaths, dose-limiting toxicities or treatment-emergent adverse events leading to treatment interruption or study discontinuation. FT2109 also demonstrated dose-proportional pharmacokinetics and a half-life supporting once-daily oral administration.
“These Phase 1 data mark an important milestone for Forward. The strength of the Phase 1 profile gives us confidence to move FT2109 into Phase 2 and pursue its development across a range of chronic inflammatory autoimmune diseases,” said Ulrich Thienel, M.D., Ph.D., Chief Medical Officer of Forward Therapeutics.
FT2109 is designed to selectively target soluble TNF (sTNF)-driven TNFR1 signaling while preserving membrane TNF (mTNF)-mediated signaling. In preclinical studies, FT2109 showed a differentiated profile, including high selectivity for sTNF, anti-inflammatory activity comparable to biologic TNF inhibition in preclinical disease models, and preservation of host-defense responses in a bacterial challenge model.
“FT2109 represents a differentiated oral approach to targeting the clinically validated TNF pathway,” added Ewan Taylor, Ph.D., Chief Scientific Officer of Forward Therapeutics. “FT2109 preclinical data showed biologic-like anti-inflammatory activity and preservation of anti-bacterial responses. Together with the Phase 1 profile, these findings reinforce the potential of FT2109 to provide meaningful and durable efficacy to patients.”
Forward’s ACR Convergence 2026 Presentation Details
Title: First-in-Human Single and Multiple Ascending Dose Study of FT2109, a Selective Oral TNFR1 Signaling Inhibitor, in Healthy Participants
Presenting Author: Ulrich Thienel, M.D., Ph.D.
Poster Number: 1408
Session: Poster Session B, Rheumatoid Arthritis – Treatment
Date: Monday, November 9, 2026
Time: 10:30 AM – 12:30 PM ET
Title: Discovery and preclinical characterization of FT2109, a differentiated oral TNFR1 signaling inhibitor
Presenting Author: Ewan Taylor, Ph.D.
Poster Number: 0081
Session: Poster Session A, Rheumatoid Arthritis – Translational Models and Mechanisms
Date: Sunday, November 8, 2026
Time: 10:30 AM – 12:30 PM ET
The abstracts are available through the ACR Convergence 2026 online program.
About FT2109
FT2109 is an 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 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
