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Spyre Therapeutics, LLC

Spyre Therapeutics, LLC logo
🇺🇸United States
Ownership
Public
Established
2013-01-01
Employees
101
Market Cap
$1.4B
Website
http://www.spyre.com

Spyre Therapeutics Initiates Phase 1 Trial of Novel Long-Acting IL-23 Antibody for IBD Treatment

• 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.

Focused Ultrasound Shows Promise in Alzheimer's Treatment

• A clinical trial using focused ultrasound to treat Alzheimer’s disease has shown promising results, marking a potential new direction in treating this debilitating condition. • The study, published in the Journal of Neurosurgery, highlights the noninvasive nature of focused ultrasound as a key advantage in Alzheimer's treatment. • Researchers are optimistic about the potential of this approach to offer a new therapeutic avenue for patients suffering from Alzheimer's disease. • Further research is needed to fully understand the long-term effects and optimal use of focused ultrasound in Alzheimer's treatment.

Spyre Therapeutics' SPY001 Shows Promising Phase 1 Results for IBD Treatment

• 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 Announces Positive Interim Phase 1 Results for SPY001 in Healthy Volunteers

• 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 Accelerates SPY003 (IL-23p19) Clinical Timelines Based on Preclinical Data

• 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.
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