Spyre Therapeutics Begins Dosing in Phase 1 Trial of SPY003 IL-23 Antibody

Spyre Therapeutics, Inc., a biotechnology firm specializing in advanced antibody engineering for immune-mediated diseases, has initiated a Phase 1 clinical trial for their investigational drug, SPY003. The trial marks Spyre's fourth on-time clinical trial start within nine months, highlighting their commitment to innovation in the treatment of Inflammatory Bowel Disease (IBD) and related conditions.

SPY003 is a novel monoclonal antibody with an extended half-life, targeting the interleukin-23 (IL-23) protein. This protein plays a crucial role in inflammatory processes, and its inhibition has shown promise in treating IBD. The investigational drug has exhibited significant potential for less frequent dosing, possibly quarterly or biannually, which may provide improved efficacy and convenience compared to first-generation anti-IL-23 monoclonal antibodies.

The ongoing Phase 1 trial is a double-blind, placebo-controlled study, aiming to evaluate the safety and pharmacokinetics of SPY003. Approximately 56 healthy adult volunteers will be enrolled in this study, which prioritizes safety as its primary endpoint while pharmacokinetics serves as a secondary endpoint. Interim results concerning safety and pharmacokinetics are anticipated in the latter half of 2025.

In preclinical studies, SPY003 displayed equivalent potency to risankizumab, a standard treatment, in inhibiting pSTAT signaling and IL-17 production. Notably, the drug demonstrated a significantly longer half-life in non-human primates, suggesting its potential to be administered to humans as infrequently as once every six months. This characteristic could mark a substantial improvement in the treatment regimen for patients with IBD, who often face the burden of frequent dosing schedules.

Spyre's strategic approach involves integrating SPY003 into a planned Phase 2 study on ulcerative colitis, pending favorable interim results from the Phase 1 trial. This upcoming study will explore six investigational therapies, both as monotherapies and in combination treatments, aiming to enhance therapeutic outcomes for patients.

The company's efforts are led by Dr. Deanna Nguyen, Senior Vice President of Clinical Development at Spyre, who expressed optimism about SPY003's potential to be a best-in-class IL-23 antibody. Nguyen emphasized the drug's promise as a compelling partner in combination therapies with Spyre's other antibodies targeting α4β7 and TL1A, which are designed for quarterly or bi-annual administration.

Spyre Therapeutics is dedicated to developing next-generation treatments for IBD and other immune-mediated diseases through innovative antibody engineering and dose optimization. The company's pipeline includes extended half-life antibodies aimed at various targets, offering hope for more effective and convenient therapeutic options.

This advancement in SPY003's clinical development highlights the potential for significant improvements in the management of chronic inflammatory conditions, providing a glimpse into the future of less burdensome and more effective treatment strategies for patients worldwide. Spyre's ongoing commitment to research and development underscores the importance of innovative approaches in addressing complex health challenges.