Spyre Launches Phase 1 Trials For Anti-TL1A Inflammatory Bowel Disease Therapy

Spyre Therapeutics, Inc., a clinical-stage biotech company focused on innovative inflammatory bowel disease (IBD) treatments, has begun dosing healthy volunteers in Phase 1 trials of two experimental half-life extended anti-TL1A monoclonal antibodies.

Josh Friedman, M.D., PhD, SVP of Clinical Development at Spyre, said in a statement, "TL1A inhibition has demonstrated compelling efficacy in ulcerative colitis and Crohn's disease patients and has been shown in pre-clinical IBD models to provide additive benefit when used in combination with other targeted agents. Further, TL1A is implicated in numerous inflammatory and fibrotic diseases beyond IBD."

He also commented, "Our SPY002 molecules were engineered to build upon the evidence from first-generation molecules with optimised properties including picomolar potencies, extended half-lives, and high-concentration formulations."

The SPY002 Phase 1 trials are randomised, double-blind, placebo-controlled studies designed to evaluate single ascending doses in approximately 56 healthy adult participants per trial. The primary goal is to assess safety, while secondary endpoints include pharmacokinetics (PK). Interim data on safety, PK, and pharmacodynamics (PD) are expected in the second quarter 2025. Based on these results, Spyre plans to advance the SPY002 program to Phase 2 trials later in 2025.

Cameron Turtle, D.Phil., Chief Executive Officer of Spyre, commented, "Entering the clinic with two optimised anti-TL1A molecules is an exciting next step as we build upon our compelling Phase 1 results for our next-generation anti-α4β7 antibody, SPY001, which exhibited a greater than 90-day half-life enabling quarterly or twice annual dosing in maintenance. Pending Phase 1 success and regulatory feedback, we look forward to introducing one of the SPY002 molecules into our groundbreaking Phase 2 platform study of monotherapies and combination therapies in ulcerative colitis next year, as well as initiating an efficient Phase 2 proof-of-concept study outside of IBD."

He also said, "Both of these studies are fully financed following our recent oversubscribed financing. The first-in-human study for SPY003, our extended half-life IL-23 antibody, remains on track to initiate in the first quarter of 2025, marking our fourth optimised antibody to initiate clinical trials within nine months."

As of September 30, 2024, Spyre reported a pro forma cash balance of approximately $630.1 million. This includes $414.2 million in cash, cash equivalents, and marketable securities.