Dive Brief:

• An experimental drug from Spyre Therapeutics helped lower signs of disease activity and improve remission rates in a Phase 2 study of people with ulcerative colitis. 
• After 12 weeks of treatment, patients who received “SPY001” in the trial had a statistically significant, 9.2-point reduction on a scoring system that assesses the severity of their disease, meeting the study’s primary objective. Notably, treatment was also associated with a 40% remission rate and a 51% improvement on endoscopic imaging. One severe adverse event was reported — chest pain in a 68-year-old male with a history of cardiovascular disease — but was deemed unrelated to treatment.
• Spyre said the findings were “clinically meaningful” and support SPY001’s “best-in-class profile.” The drug is one of multiple therapies the company is evaluating in Phase 2 trials in inflammatory bowel disease. Proof-of-concept data for two other therapies in the trial are expected later this year. Data from a placebo-controlled portion of the study are on track for 2027. 

Dive Insight:

Spyre is one of multiple companies antibody drug specialist Paragon Therapeutics has created and taken public via reverse mergers. Like Spyre, a few others — such as the the immune drugmaker Apogee Therapeutics and skin disease-focused Oruka Therapeutics — are worth several billions of dollars. 

Spyre’s specific focus is inflammatory bowel disease, or IBD. The company has several drugs in its portfolio, all of which are aimed at well-known targets and aim to improve upon therapies either in development or already on the market. 

SPY001, for instance, goes after a protein known as as α4b7, like Takeda’s blockbuster drug Entyvio, but could have longer-lasting effects. Other candidates in its pipeline aim at TL1A — the focus of lots of recent industry deals — or IL-23, like AbbVie’s Skyrizi and Johnson & Johnson’s Tremfya. Some prospects home in on more than one of those proteins simultaneously. 

The early data presented Monday is the first reveal from a multi-pronged study testing several of those therapies. In this part of the trial, Spyre evaluated SPY001 in 43 people with moderately to severely active ulcerative colitis. 

While the findings weren’t from a placebo-controlled study arm, they still represent an “extremely favorable outcome” and suggest better efficacy could lay ahead in the combination portion of the trial, wrote Mizuho Securities analyst Joseph Catanzaro.

Leerink Partners’ Thomas Smith added the drug generated “class-leading efficacy” on its main and secondary goals already, which suggest “differentiated” potency compared to Takeda’s Entyvio. 

The results suggest “best-in-class potential in a convenient, infrequently dosed” under-the-skin injection, Smith wrote. 

Spyre shares surged about 25% in Monday trading.