Prometheus Biosciences Announces Initiation of APOLLO-CD Phase 2a Clinical Trial of PRA023 in Moderate-to-Severe Crohn’s Disease
SAN DIEGO, Aug. 02, 2021 (GLOBE NEWSWIRE) -- Prometheus Biosciences, Inc. (Nasdaq: RXDX), a clinical-stage 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 APOLLO-CD Phase 2a clinical trial evaluating PRA023 for moderate-to-severe Crohn’s disease (CD), with first patient enrollment.
- We believe PRA023 has the potential to address the highest unmet need of fibrostenotic disease in this patient population.
- The APOLLO-CD Phase 2a trial is an open-label study designed to evaluate the proof-of-concept efficacy and safety of PRA023 in moderate-to-severe Crohns disease with centrally read endoscopy as the primary endpoint.
- 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 this Phase 2a trial.