Spyre Therapeutics Inc. (NASDAQ: SYRE) saw its stock soar by 6.53% in pre-market trading on November 12, 2024, following the release of positive interim results from the Phase 1 trial of its investigational drug SPY001, a novel half-life extended anti-α4β7 antibody for the treatment of inflammatory bowel disease (IBD).

The Phase 1 trial, which evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of SPY001 in healthy volunteers, demonstrated several promising findings that have fueled investor optimism:

• SPY001 exhibited a favorable safety profile, with no serious adverse events reported across all dose levels tested.
• The PK data revealed a remarkable half-life of over 90 days for SPY001, approximately four times longer than vedolizumab, the currently approved anti-α4β7 antibody. This extended half-life supports the potential for less frequent dosing, such as once every 3 or 6 months, via a single subcutaneous injection.
• The PD data showed complete saturation of the α4β7 receptor occupancy up to the longest follow-up timepoint available (12 weeks), suggesting the potential for increased or accelerated efficacy compared to existing therapies.

Based on these encouraging interim results, Spyre Therapeutics plans to initiate a Phase 2 platform trial in mid-2025, which will evaluate SPY001 as a monotherapy and in combination with the company's other investigational drugs targeting TL1A (SPY002) and IL-23 (SPY003) for the treatment of IBD.