A Delaware-based pharmaceutical company announced Monday that their experimental treatment for ulcerative colitis showed promising results in reducing inflammation during a mid-stage clinical trial.
Spyre Therapeutics reported that their investigational medication, SPY001, successfully achieved its primary endpoint by decreasing key inflammation markers at the tissue level following 12 weeks of treatment.
Ulcerative colitis affects patients with chronic inflammation that creates swelling and sores throughout the colon and rectum lining.
During the clinical trial, researchers found that 40% of participants reached clinical remission while 51% demonstrated noticeable improvements in their intestinal tissue condition.
According to Spyre, SPY001 is engineered to enhance the effectiveness of Takeda Pharmaceutical’s existing treatment Entyvio, offering extended duration of action and improved initial dosing protocols.
The safety profile remained favorable, with only six participants experiencing treatment-related adverse reactions during the initial treatment phase. One serious adverse event occurred but was determined to be unconnected to the study drug. Back pain emerged as the most frequently reported side effect, affecting two study participants.
The ongoing mid-stage clinical trial consists of two distinct phases: an initial open-label segment followed by a randomized, placebo-controlled portion that will evaluate multiple Spyre medications both individually and in combination therapies.
The FDA granted approval for Takeda’s Entyvio to treat moderate to severe ulcerative colitis in May 2014, with a subcutaneous formulation receiving approval in September 2023.
