By Siddhi Mahatole
April 13 (Reuters) – Spyre Therapeutics said on Monday its experimental drug showed a significant reduction in disease activity when tested in patients with ulcerative colitis in a mid-stage study, sending its shares up 24.4% before the bell.
The drug, SPY001, met the trial’s main goal by reducing a key measure of tissue-level inflammation after 12 weeks of treatment, the drug developer said.
Ulcerative colitis is a chronic inflammatory disease causing swelling and ulcers in the lining of the colon and rectum.
In the study, 40% of patients achieved clinical remission and 51% showed visible improvement in intestinal tissue.
SPY001 is designed to build on the activity of Takeda Pharmaceutical’s Entyvio, with a longer-lasting effect and higher induction dosing, Spyre said.
Six patients reported treatment-emergent adverse events during the induction period, including one serious event unrelated to the drug. The most common side effect was back pain, which was reported by two patients.
“It is very encouraging that SPY001 not only beat benchmarks on remission, but also on endoscopic improvement, reflecting deeper disease control and potential best-in-class profile,” said Jones Trading analyst Debanjana Chatterjee.
The mid-stage trial has two parts: an initial open-label phase followed by a randomized, placebo-controlled phase testing multiple Spyre drugs alone and in combination.
“If SPY001 indeed shows superior efficacy in placebo-controlled trials, it could take away Entyvio’s market share, even if marketed as a monotherapy,” Chatterjee added.
Takeda’s Entyvio was approved by the U.S. Food and Drug Administration for moderately to severely active ulcerative colitis in May 2014; a subcutaneous version was approved in September 2023.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Tasim Zahid and Shailesh Kuber)
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