Benzinga | Jul 19, 2021 08:11AM EDT

Prometheus Biosciences Announces Initiation Of Global Phase 2 Clinical Trial Of PRA023 In Moderate-To-Severe Ulcerative Colitis

Prometheus Biosciences, Inc. (NASDAQ:RXDX), a biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today announced the initiation of the Phase 2 ARTEMIS-UC clinical trial evaluating PRA023 for moderate-to-severe ulcerative colitis (UC), with first patient enrollment. The study is placebo-controlled and statistically powered to evaluate the efficacy and safety of PRA023 in UC patients. The company plans to provide more details of the Phase 2 ARTEMIS-UC study at R&D Day on July 28th.

"The majority of patients with UC cannot achieve clinical remission through the use of currently available therapies," said Allison Luo, MD, Chief Medical Officer of Prometheus. "This gives Prometheus compelling motivation to rapidly advance PRA023, addressing both inflammation and fibrosis and leading the precision medicine approach in the IBD space, starting first with the ARTEMIS-UC study."

Prometheus has recently completed the dosing phase of the Phase 1a clinical trial of PRA023, a single center, double-blind, placebo-controlled trial to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in normal healthy volunteers. Safety and tolerability observed to date supports the initiation of a Phase 2 trial. Final Phase 1a results of PRA023 in UC and CD are expected in the fourth quarter of 2021. Further details will be provided at the company's R&D Day on July 28, 2021. Register here: Prometheus R&D Day