Spyre's bowel disease drug meets goals in mid-stage trial

Spyre Therapeutics (SYRE) said its experimental ulcerative colitis treatment significantly reduced disease severity in a mid-stage clinical trial, marking a key milestone for the biotech's inflammation pipeline.

The company said its drug, SPY002, met the primary endpoint of the trial, cutting scores on a microscopic inflammation assessment by 10.7 points after 12 weeks in patients with moderate-to-severe ulcerative colitis — a condition that causes chronic ulcers and inflammation in the digestive tract.

Secondary results showed 33% of patients achieved clinical remission, while 42% demonstrated improvement on endoscopy, indicating visibly reduced inflammation of the colon. The study enrolled patients with longstanding disease, averaging roughly seven years of diagnosis, with more than a third having previously received advanced therapies.

SPY002 is an engineered antibody designed to remain active in the body for longer than conventional treatments, targeting TL1A, a protein implicated in driving inflammation and tissue damage in inflammatory bowel disease.

The drug was well tolerated, Spyre said, with a safety profile in line with other TL1A-targeting agents. The most commonly reported side effects included joint pain, high blood pressure, nausea, ulcerative colitis flares, and viral respiratory infections.

The trial forms part of a two-part mid-stage study evaluating three investigational drugs — SPY001, SPY002, and SPY003 — both individually and in combination in patients with moderate-to-severe ulcerative colitis.