Benzinga | Aug 2, 2021 08:06AM EDT

Prometheus Biosciences Announces Initiation Of APOLLO-CD Phase 2a Clinical Trial Of PRA023 In Moderate-To-Severe Crohn's Disease

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 are excited to advance PRA023 into the APOLLO-CD Phase 2a study as we believe its novel mechanism of action, designed to address both inflammation and fibrosis, can have a significant impact on patients suffering with Crohn's disease," said Allison Luo, MD, Chief Medical Officer of Prometheus. "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 Crohn's disease with centrally read endoscopy as the primary endpoint. Dosing regimen of the 50 subjects in the study will consist of 1,000 mg on day 1, followed by 500 mg on weeks 2, 6, and 10 for a total of 12 weeks on therapy. The primary endpoint at week 12 will evaluate the proportion of patients achieving endoscopic improvement as defined by 50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD), which assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. Each subject will also be assessed for the status of companion diagnostic (CDx) assay we are developing and subgroup analyses for all endpoints will be conducted based on CDx results.

"Clinicians and patients are excited about Prometheus' precision approach coupled with the anti-fibrotic mechanistic approach of the anti-TL1A therapy," said Dr. G. Aaron Duvall, gastroenterologist and investigator at Tyler Research Institute. "I am thrilled to participate in both the ulcerative colitis and Crohn's disease studies to help bring this novel therapeutic approach, with the use of a companion diagnostic, to patients."

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. Final Phase 1a results of PRA023 are expected in the fourth quarter of 2021. Separately, Prometheus recently initiated and dosed the first patient in the ARTEMIS-UC Phase 2 trial to evaluate the efficacy and safety of PRA023 in moderate-to-severe ulcerative colitis (UC) patients.