Clinical Trials
9
5 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2013
Active, not recruiting
2
22.2%
Completed
3
33.3%
Enrolling By Invitation
1
11.1%
Not yet recruiting
2
22.2%
Recruiting
1
11.1%
No approval data available
- Spyre Therapeutics' experimental drug SPY001 achieved a statistically significant 9.2-point reduction in disease activity scores in a Phase 2 study of 43 patients with moderate to severe ulcerative colitis. - The treatment demonstrated a 40% remission rate and 51% improvement on endoscopic imaging after 12 weeks, with only one severe adverse event reported that was deemed unrelated to treatment. - SPY001 targets the α4β7 pathway similar to Takeda's Entyvio but potentially offers longer-lasting effects, with analysts describing the results as showing "class-leading efficacy" and "best-in-class potential." - The positive results led to a 25% surge in Spyre shares and position the company to compete with major drugmakers in the inflammatory bowel disease market.
- Spyre Therapeutics has completed a Phase 1 randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of SPY001-001 in healthy participants. - The first-in-human study utilized single and multiple ascending dose protocols with stepwise dose-escalation to establish basic safety profiles before advancing to patient trials. - Completion of this Phase 1 trial reduces early development risk for the company and supports future dose selection decisions and Phase 2 planning. - The study was initiated in June 2024 and recently completed, though detailed safety results have not yet been publicly disclosed.
- Spyre Therapeutics announced six expected proof-of-concept readouts in 2026 across its SKYLINE platform trial in ulcerative colitis and SKYWAY basket trial in rheumatic diseases. - The company's SPY003 anti-IL-23 antibody demonstrated well-tolerated safety profile with differentiated pharmacokinetics supporting quarterly or twice-yearly dosing in Phase 1 studies. - SKYLINE platform trial enrollment exceeded expectations with SPY001 enrollment completed ahead of schedule, accelerating Part A readouts to begin in Q2 2026. - Preclinical data showed dual targeting of TL1A and IL-23 provided superior efficacy compared to either agent alone in mouse colitis models.
- Spyre Therapeutics has dosed the first participant in a Phase 1 trial of SPY003, a half-life extended IL-23 antibody designed for potential quarterly or biannual dosing in inflammatory bowel disease patients. - Preclinical data indicates SPY003 demonstrates equivalent potency to risankizumab while offering significantly extended half-life, potentially improving both efficacy and treatment convenience compared to first-generation IL-23 inhibitors. - The company plans to incorporate SPY003 into a comprehensive Phase 2 platform trial for ulcerative colitis that will evaluate three monotherapies and three combination therapies, with interim Phase 1 data expected in the second half of 2025.
- Spyre Therapeutics' SPY001 demonstrates a >90-day half-life in Phase 1 trials, suggesting potential for quarterly or bi-annual subcutaneous maintenance dosing in IBD. - The Phase 1 trial shows SPY001 is well-tolerated with a favorable safety profile, supporting further development as a next-generation anti-α4β7 therapy. - SPY001 achieved complete saturation of α4β7 receptors, indicating strong target engagement and potential for improved efficacy in treating ulcerative colitis and Crohn's disease. - Spyre plans to initiate a Phase 2 platform trial in mid-2025 to evaluate SPY001, SPY002 (TL1A), SPY003 (IL-23), and combinations, aiming for optimized monotherapy and combination readouts.
- Spyre Therapeutics reports positive interim results from its Phase 1 trial of SPY001, a novel half-life extended anti-α4β7 antibody. - The trial, conducted on healthy volunteers, aimed to assess the safety, tolerability, and pharmacokinetics of SPY001. - SPY001 is being developed for the treatment of inflammatory bowel disease (IBD) with the goal of improved efficacy and convenience. - Spyre plans to present further details on the interim results during a conference call and webcast on November 12, 2024.
- Spyre Therapeutics is progressing its SPY001 program, an anti-a4ß7 monoclonal antibody, with interim Phase I data expected by year-end for IBD treatment. - The company anticipates initiating a Phase I study for its SPY002 program in the second half of 2024, following IND-enabling studies. - SPY003, another IBD program, is on track for development candidate nomination by mid-year and IND-enabling studies in the latter half of 2024. - With a strong cash position of $485 million as of March 31, 2024, Spyre is well-funded to advance its pipeline through key milestones.
- Spyre Therapeutics anticipates initiating first-in-human dosing of SPY003, a novel half-life extended anti-IL-23 monoclonal antibody, in Q1 2025, with interim data expected in the second half of 2025. - Preclinical data presented at UEGW demonstrated SPY003's comparable potency to risankizumab and a greater than three-fold increase in half-life in non-human primates. - Spyre also presented preclinical data on combining anti-IL-23 with anti-α4β7 or anti-TL1A, showing enhanced efficacy in in vitro and in vivo models of IBD. - The company's portfolio now includes extended half-life molecules targeting α4β7, TL1A, and IL-23, potentially enabling Q8W-Q12W maintenance dosing for IBD patients.
