Spyre Therapeutics, Inc. announced positive interim Phase 1 data from its first-in-human trial of SPY001, an investigational anti-α4β7 antibody for inflammatory bowel disease (IBD). The data, as of October 30, 2024, showed SPY001 was well tolerated with a favorable safety profile across all dose groups.
Pharmacokinetic (PK) data demonstrated a half-life of over 90 days, which is approximately four-fold greater than vedolizumab's estimated 25-day human half-life. This extended half-life supports the potential for maintenance dosing via a single subcutaneous injection on a quarterly (Q3M) or biannual (Q6M) basis.
Pharmacodynamic (PD) data indicated complete saturation of α4β7 receptors with a single 300 mg dose through Week 12, the longest follow-up available. Based on these results, Spyre plans to initiate a Phase 2 platform trial in ulcerative colitis in mid-2025, which will include SPY001, SPY002, SPY003, and combinations.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.