Spyre Therapeutics Inc. (NASDAQ: SYRE) reported positive 12-week results from its Phase 2 SKYLINE trial of SPY002, an investigational anti-TL1A antibody for treating moderate-to-severe ulcerative colitis.

The trial met its primary endpoint with SPY002 showing a statistically significant 10.7-point reduction from baseline in Robart's Histopathology Index score at week 12 (p<0.0001). Secondary endpoints included a clinical remission rate of 33% by modified Mayo Score and endoscopic improvement rate of 42%.

The study enrolled 48 patients, with 35% having prior advanced therapy exposure and a mean disease duration of 7.0 years. The baseline mean RHI score was 16.9 ± 8.5, and 56% of participants had a baseline endoscopy score of 3.

Safety data showed 20 subjects experienced treatment-emergent adverse events during the induction period. Two serious adverse events occurred - one hospitalization for ulcerative colitis exacerbation and another for heart failure worsening in a patient with existing heart failure history. Both were deemed unrelated to the drug. The most common adverse events were hypertension (3 patients), arthralgia (2 patients), nausea (2 patients), ulcerative colitis (2 patients), and viral respiratory tract infection (2 patients).

SPY002 is an extended half-life antibody targeting TL1A, a cytokine involved in chronic inflammation and fibrosis in inflammatory bowel disease. The company is now enrolling Part B of the SKYLINE trial, which will evaluate combination therapies.

"These data build upon our impressive SPY001 results and reinforce our thesis that optimized monotherapy components are the foundation for potentially best-in-class combinations," said Deanna Nguyen, M.D., SVP of Clinical Development.

The information is based on a company press release statement.