BOSTON, Nov. 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 that the U.S. Food and Drug Administration (FDA) has cleared the Company’s investigational new drug (IND) application to initiate a Phase 2 proof-of-concept study of FT2109, its novel, potential best-in-class oral selective soluble TNF signaling inhibitor, in patients with active psoriatic arthritis (PsA). Forward plans to initiate the study in December 2026.

In preclinical studies, FT2109 showed a differentiated profile, including high potency and oral bioavailability, anti-inflammatory activity comparable to biologic TNF inhibition in preclinical disease models, and preservation of host-defense responses in a bacterial challenge model. The program is advancing into Phase 2 following a completed Phase 1 study in 90 healthy participants in which FT2109 was well tolerated across the evaluated dose range and demonstrated dose-proportional pharmacokinetics supporting once-daily oral dosing.

“IND clearance marks an important milestone for FT2109 as we move from establishing its clinical profile in healthy volunteers to evaluating its potential in patients with inflammatory disease,” said Ulrich Thienel, M.D., Ph.D., Chief Medical Officer of Forward. “TNF is a clinically validated driver of psoriatic arthritis, and we believe FT2109’s selective mechanism and oral profile have the potential to offer a differentiated approach to targeting this pathway. We look forward to initiating the Phase 2 study and generating the proof-of-concept data needed to further define the program’s potential across chronic inflammatory autoimmune diseases.”

The Phase 2 study (FT2109-2201) is a randomized, double-blind, placebo-controlled proof-of-concept trial designed to evaluate the efficacy and safety of two once-daily doses of FT2109 in approximately 210 adults with active PsA, including both biologic-naïve and biologic-experienced patients. Participants will be randomized to receive FT2109 or placebo for 12 weeks, in addition to permitted background therapy.

The primary endpoint is the proportion of patients achieving at least a 20% improvement according to American College of Rheumatology criteria (ACR20) at Week 12. Secondary assessments will evaluate safety and tolerability and additional measures of disease activity and clinical response, including ACR50 and ACR70 responses, minimal and very low disease activity, Disease Activity in Psoriatic Arthritis (DAPSA) and improvements in psoriasis severity.

Psoriatic arthritis is a chronic systemic inflammatory disease affecting the joints and skin and can include peripheral arthritis, axial disease, dactylitis and enthesitis. Despite multiple approved therapeutic options, many patients do not achieve sustained remission, underscoring the need for additional treatment approaches. TNF is a well-established therapeutic target in PsA and plays a central role in amplifying inflammatory signaling and contributing to tissue damage.

About Forward Therapeutics

Forward Therapeutics is a clinical-stage biopharmaceutical company advancing a pipeline of novel, internally discovered oral small-molecule therapies for inflammation-driven diseases. The Company's multidisciplinary team brings together deep expertise in structure-based drug design, discovery, and development to identify and optimize differentiated molecules against challenging therapeutic targets. 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 Forward’s investigational therapies, and Forward’s 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 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

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