An investigative medicine from Prometheus Biosciences met its goals in a pair of Phase 2 studies enrolling patients with inflammatory bowel disease, setting the stage for pivotal trials and nearly doubling the company’s stock price.
In an ulcerative colitis study enrolling about 130 volunteers, Prometheus’ drug helped nearly 27% of patients reach clinical remission, defined as an absence of serious symptoms, compared to 1.5% for the placebo group, the company said. The study also met its secondary goals, showing endoscopic, histologic, and patient-reported benefits. In a second, open-label trial enrolling 55 patients with Crohn’s disease, 26% had a response to the drug that showed up on endoscopy, while 49% went into clinical remission.
Prometheus’ drug, called PRA023, led to no serious side effects, no reactions that led patients to leave the study, and no opportunistic infections, a common risk for medicines that modulate the immune system.
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