Spyre Therapeutics announced on Monday that its experimental drug demonstrated a significant reduction in disease activity in patients with ulcerative colitis during a mid-stage clinical trial, leading to a 34.5% surge in its share price.
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 long-term inflammatory condition that causes inflammation and sores in the lining of the colon and rectum.
Read Also – Mail-order services now dominate the dispensing of abortion pills in the United States
The Waltham, Massachusetts-based company said it expects the inflammatory bowel disease market to grow to around $40 billion by 2030.
In the study, 40% of patients achieved clinical remission, while 51% showed noticeable improvement in intestinal tissue.
Spyre CEO Cameron Turtle stated that the efficacy results for SPY001 were better than those reported for each individual component of Johnson & Johnson’s VEGA mid-stage combination trial.
“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 experienced treatment-emergent adverse events during the induction period, including one serious case that was not related to Spyre’s drug. The most frequently reported side effect was back pain, which occurred in two patients.
The mid-stage trial is conducted in two phases: an initial open-label stage, followed by a randomized, placebo-controlled stage that evaluates multiple Spyre drugs both individually 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 first approved by the U.S. Food and Drug Administration for ulcerative colitis in May 2014, with a subcutaneous formulation receiving approval in September 2023.
