Spyre’s inflammatory bowel drug shown to reduce disease activity in mid-stage study

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 34.5%.

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.

The Waltham, Massachusetts-based company said it expects the inflammatory bowel disease market to reach about $40 billion by 2030.

In the study, 40% of patients achieved clinical remission and 51% showed visible improvement in intestinal tissue.

Spyre Chief Executive Cameron Turtle said the efficacy data for SPY001 exceeded results reported for each individual component of Johnson & Johnson’s VEGA (mid-stage) combination trial nPn6y1whna.

“On certain endpoints, our SPY001 monotherapy matched or even exceeded the efficacy of J&J’s combination,” Turtle said on a call with analysts.

Six patients reported treatment-emergent adverse events during the induction period, including one serious event unrelated to Spyre’s drug. The most common side effect was back pain, which was reported by two patients.

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.

SPY001 is designed to build on the activity of Takeda Pharmaceutical’s Entyvio, with a longer-lasting effect and higher induction dosing, Spyre said.

“If SPY001 indeed shows superior efficacy in placebo-controlled trials, it could take away Entyvio’s market share, even if marketed as a monotherapy,” said Jones Trading analyst Debanjana Chatterjee.

Takeda’s Entyvio was approved by the U.S. Food and Drug Administration for ulcerative colitis in May 2014, followed by a subcutaneous version in September 2023.

(Reporting by Siddhi Mahatole in Bengaluru; Editing by Tasim Zahid and Shailesh Kuber)