Spyre Therapeutics is discontinuing the development of its anti-TL1A antibody, SPY072, for rheumatic conditions after the drug failed to meet primary endpoints in a phase 2 basket trial. According to BioPharm International, the company reported that the drug was well tolerated in the SKYWAY study, which evaluated patients with psoriatic arthritis and axial spondyloarthritis, but did not disclose specific response rates for these cohorts.
The decision follows mixed results in a separate rheumatoid arthritis study. While the low dose of SPY072 met its primary endpoint, the high dose failed to do so, and the company determined that the overall effect size did not reach its internal threshold for continued investment.
Strategic Shift to Hidradenitis Suppurativa
Spyre is now pivoting its focus toward hidradenitis suppurativa. This move follows positive phase 2b data released by Merck for its own anti-TL1A antibody, tulisokibart, in the same indication.
The company is currently conducting the phase 2 SKYLIGHT trial, which evaluates SPY072 in combination with the IL-17A/F inhibitor bimekizumab. Spyre plans to initiate key studies for an anti-TL1A monotherapy specifically for hidradenitis suppurativa in 2027.
Biora Therapeutics Initiates Capsule Study
In other clinical developments, Biora Therapeutics has received approval from an Australian Human Research Ethics Committee to conduct a first-in-human trial of its BioJet ingestible capsule. The device is designed to deliver adalimumab directly into the small intestine using liquid jet technology.
The upcoming study will enroll healthy volunteers to compare the oral delivery method against traditional subcutaneous injections. Researchers plan to assess the capsule’s safety, tolerability, and pharmacokinetics, with initial dosing scheduled for December. While more than 800 capsules have been administered in animal models, this trial marks the first time the technology will be tested in humans, with data expected in early 2027.
We recently announced a $350M financing to support the advancement of SPY072 into late-stage development for hidradenitis suppurativa. This brings Spyre’s total capital raised to more than $2B since inception, with a pro forma cash position of ~$1.5 billion*. pic.twitter.com/3Prek0NYA2
Spyre Stops Rheumatic Disease Development After Trial Misses Endpoints
Why did Spyre Therapeutics decide to stop development for rheumatic diseases?
The company halted development because SPY072 missed its primary endpoints in psoriatic arthritis and axial spondyloarthritis during the phase 2 SKYWAY trial. Additionally, results in rheumatoid arthritis were considered insufficient to meet the company’s internal efficacy standards.
What is the status of the Biora Therapeutics BioJet trial?
The trial has received ethics approval in Australia and is set to begin dosing healthy volunteers in December. The study aims to generate the first human data on the capsule’s ability to deliver medication, with results anticipated by early 2027.