SPY072 / Spyre Therap - LARVOL DELTA

Spyre Therapeutics Announces Positive Interim Phase 1 Results for SPY003, Its Novel, Half-Life Extended anti-IL-23 Antibody (GlobeNewswire) - "SPY003 was well tolerated at all dose levels, with a favorable safety profile consistent with the anti-IL-23 class. There were two Grade 2 or above treatment-emergent adverse events (TEAEs), both deemed not treatment-related, and no serious adverse events were observed in the study....SPY003 expected to advance to the ongoing Part A of the SKYLINE Ph2 platform trial. SKYLINE and SKYWAY trials are expected to provide 6 proof-of-concept readouts in 2026."

P1 data • P2 data • Trial status • Inflammatory Bowel Disease • Psoriatic Arthritis • Rheumatoid Arthritis • Spondylarthritis

Spyre Therapeutics Announces Poster Presentations at American College of Rheumatology (ACR) Convergence 2025 (The Manila Times) - "'The data continue to show SPY072 is well tolerated, has a differentiated PK profile supporting quarterly or twice-yearly dosing, and suppresses free TL1A through 20 weeks at the lowest dose....Additionally, we are pleased to share new preclinical data demonstrating that anti-TL1A antibody treatment meets or exceeds the efficacy of etanercept in a rodent model of collagen-induced arthritis...'"

P1 data • Preclinical • Rheumatoid Arthritis

SKYWAY-RD: A Study of SPY072 in Rheumatic Disease (clinicaltrials.gov) - P2 | N=285 | Recruiting | Sponsor: Spyre Therapeutics, Inc. | Trial primary completion date: Mar 2028 ➔ Oct 2026

Trial primary completion date • Ankylosing Spondylitis • Hematological Disorders • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Spyre Therapeutics Doses First Patient in Pioneering Phase 2 SKYWAY Basket Trial of SPY072, the First Anti-TL1A Antibody Studied in Rheumatic Diseases (GlobeNewswire) - "SKYWAY study is evaluating SPY072 in patients with moderate-to-severely active rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA). Proof-of-concept data for all three indications are expected in 2026."

P2 data • Trial status • Psoriatic Arthritis • Rheumatoid Arthritis • Spondylarthritis

SKYWAY-RD: A Study of SPY072 in Rheumatic Disease (clinicaltrials.gov) - P2 | N=285 | Recruiting | Sponsor: Spyre Therapeutics, Inc.

New P2 trial • Ankylosing Spondylitis • Hematological Disorders • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

SKYWAY-RD: Basket Phase 2 trial of anti-TL1A in Three Rheumatologic Conditions (PRNewswire) - "SKYWAY-RD is a planned Phase 2 randomized and placebo-controlled basket trial of SPY072 in patients with moderately to severely active RA, PsA, or axSpA with inadequate response to conventional or advanced therapies. RA sub-study: Double-blind, placebo-controlled safety and efficacy study of two dose levels of SPY072 through Week 12 with open-label follow-up through Week 36; PsA sub-study: Double-blind, placebo-controlled safety and efficacy study of a single dose level of SPY072 through Week 16 with open-label follow-up through Week 40; axSpA sub-study: Double-blind, placebo-controlled safety and efficacy study of a single dose level of SPY072 through Week 16 with open-label follow-up through Week 40...Topline proof-of-concept data are expected in 2026."

New P2 trial • P2 data • Immunology • Inflammation • Psoriatic Arthritis • Rheumatoid Arthritis

Spyre Therapeutics Announces Positive Interim Phase 1 Results for Two Next-Generation TL1A Antibody Programs, and Provides Clinical Development Updates Expected to Deliver 9 Phase 2 Readouts (PRNewswire) - P1 | N=56 | NCT06622070 | NCT06672718 | Sponsor: Spyre Therapeutics, Inc | "Interim results from the Phase 1 trials for SPY002 and SPY072, with data reported as of May 30, 2025, met all Phase 1 objectives, supporting their potential to become next-generation anti-TL1A monotherapies in immune-mediated diseases or as elements of combination therapies. Single doses of up to 1500 mg for SPY002 and SPY072 were well tolerated with no serious adverse events reported, exhibited a prolonged half-life supportive of quarterly or less frequent dosing, and suppressed free TL1A through 20 weeks of follow up available for the lowest dose tested...SPY002 half-life is estimated at ~75 days across IV and SC SAD cohorts, more than 3-fold greater than first-generation anti-TL1As; SPY072 showed comparable PK to SPY002 at clinically relevant doses through available follow up; waiting for comparable follow-up to accurately estimate half-life."

P1 data • Immunology • Inflammation • Ulcerative Colitis

Spyre Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update (PRNewswire) - "In January 2025, the Company announced its intent to study one of its anti-TL1A antibodies in RA, with Phase 2 trial initiation expected in mid-2025 and topline results in 2026. With class-leading potency and half-life established in preclinical studies, SPY002 has the potential to become the first-in-class and best-in-class anti-TL1A treatment for RA...Company announced initiation of first-in-human ('FIH') trials of both SPY002 candidates, with healthy volunteer interim data expected in the second quarter of 2025...In March 2025, the Company initiated a FIH trial of SPY003, with healthy volunteer interim data expected in the second half of 2025....The Company expects to initiate a Phase 2 clinical trial in 2025 that is intended to include each of its rational combinations, as well as all three of its lead monotherapy programs."

Clinical data • New P2 trial • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis