Forward Therapeutics Announces Positive Phase 1 Data for FT2109

BOSTON, Oct. 05, 2026 /CourierPR/ -- Forward Therapeutics, a clinical-stage biotechnology company, has announced positive Phase 1 clinical and preclinical data for its novel, potential best-in-class oral selective TNFR1 signaling inhibitor, FT2109. The company is set to advance the drug into Phase 2 development, based on the favorable safety and tolerability profile observed in the Phase 1 study.

In a randomized, double-blind, placebo-controlled Phase 1 study involving healthy participants, FT2109 demonstrated a low overall incidence of adverse events, comparable to those seen in the placebo group. There were no serious adverse events, deaths, dose-limiting toxicities, or treatment-emergent adverse events that led to treatment interruption or study discontinuation. The drug also showed dose-proportional pharmacokinetics and a half-life supporting once-daily oral administration.

FT2109 is designed to selectively target soluble TNF (sTNF)-driven TNFR1 signaling while preserving membrane TNF (mTNF)-mediated signaling. In preclinical studies, the drug 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.

The company will present its findings at the American College of Rheumatology (ACR) Convergence 2026, taking place from November 6 to 11 in Orlando, Florida. The presentations will include:

Forward Therapeutics is advancing a pipeline of internally-discovered novel, oral small molecule therapies for inflammation-driven diseases. The company's approach, using its SWIFT™ data-driven drug discovery engine, aims to unlock high-potential, hard-to-drug targets.

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.

The release also highlights the potential of FT2109 to provide meaningful and durable efficacy to patients, with preclinical data showing biologic-like anti-inflammatory activity and preservation of anti-bacterial responses. The Phase 1 data, which are included in two abstracts accepted for presentation at the ACR Convergence 2026, are expected to support the advancement of FT2109 into Phase 2 development.