Spyre Therapeutics Initiates Phase 1 Study of SPY001, a Novel Antibody Targeting α4β7 for Inflammatory Bowel Disease Therapy
Wednesday, June 19, 2024
Spyre Therapeutics, Inc. (NASDAQ: SYRE), a biotechnology firm focused on the development of innovative treatments for Inflammatory Bowel Disease (IBD), has announced the initiation of its first clinical trial for SPY001. This investigational monoclonal antibody aims to address key mechanisms involved in IBD. Spyre has quickly moved from its public debut to clinical trials, highlighting the company's rapid progress.
Spyre Therapeutics, remarked, "Our team has made significant strides, enabling us to reach this milestone. We anticipate presenting initial safety and efficacy data for SPY001 by the end of this year, and look forward to releasing preliminary results from our T1LA program soon."
The Phase 1 trial for SPY001 is a double-blind, placebo-controlled study involving healthy volunteers. It includes phases for both single-ascending and multi-ascending doses, with about 48 participants enrolled across multiple cohorts. The primary focus of this study is on safety, with pharmacokinetics being a secondary focus. Interim data on safety and pharmacokinetics are expected by the end of 2024, and if these results are positive, Spyre plans to advance to Phase 2 development in 2025.
Dr. Deanna Nguyen, Senior Vice President of Clinical Development at Spyre, added, "The inhibition of α4β7 is well-regarded among gastroenterologists for its targeted action in the gut. SPY001 could potentially offer a convenient dosing regimen and serve as a foundational therapy in combination with other targeted treatments like T1LA and IL-23."
SPY001 is being evaluated as a subcutaneously administered monoclonal antibody designed to target α4β7 for the treatment of IBD, which includes conditions such as ulcerative colitis and Crohn’s disease. With a significant portion of the U.S. population affected by IBD, SPY001 has demonstrated in preclinical studies an ability to block MadCAM-1 adhesion similar to vedolizumab, while potentially allowing for less frequent dosing, every two to three months. The ongoing Phase 1 trial aims to provide further insights into these potential benefits, with results expected by the end of 2024, setting the stage for Phase 2 trials in 2025 based on these findings.
Source: prnewswire.com
