Spyre Therapeutics, Inc. (SYRE), a clinical-stage biotechnology company, announced positive 12-week induction data from Part A of the Phase 2 SKYLINE trial of SPY001, stating that it met the primary end point for the treatment of moderate-to-severely active ulcerative colitis (UC).
Following the news, SYRE is up 28.33%. at $65.81.
SPY001 is an extended half-life investigational antibody targeting a4ß7, an integrin central to immune cell trafficking to the gut. SKYLINE Trial Findings
SKYLINE is a two-part induction and maintenance platform trial of SPY001, SPY002, SPY003, and their pairwise combinations in patients with moderately to severely active ulcerative colitis.SKYLINE Part A is an open-label assessment of the safety and efficacy of a single dose level for each investigational monotherapy, and enrolment is complete.
SPY001 met its primary endpoint with a statistically significant reduction of 9.2 points from baseline at Week 12 in Robart's Histopathology Index (RHI) score.
Rates of the key secondary endpoints, clinical remission and endoscopic improvement, were clinically meaningful and support SPY001's profile according to the firm.
SPY001 was well tolerated with a safety profile consistent with the a4ß7 class.
What's Ahead
Enrollment is ongoing for SKYLINE Part B, a randomised, placebo-controlled assessment of the safety and efficacy of investigational monotherapies at two dose levels and combinations.
"We have begun enrolling these combinations globally and look forward to unveiling proof-of-concept data next year," said Deanna Nguyen, SVP of Clinical Development and SKYLINE study lead.
SYRE has traded between $12.04 and $75.00 over the last year. The stock closed Friday's trade at $51.29.
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