ARTEMIS-UC, APOLLO-CD topline results: PRA023 safe, effective in Crohn’s disease, UC
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Topline findings from the phase 2 ARTEMIS-UC and phase 2a APOLLO-CD trials showed that PRA023, an anti-TL1A monoclonal antibody, was safe and effective for Crohn’s disease and ulcerative colitis, Prometheus Biosciences announced.
“We are beyond enthusiastic with these study results and what they could mean for patients suffering from IBD,” Mark McKenna, chairman and CEO of Prometheus Biosciences, said in the release. “The performance of PRA023 in both UC and Crohn’s patients has surpassed our expectations. We believe PRA023 and our precision medicine approach has the potential to change the paradigm of IBD treatment and we look forward to discussions with regulatory agencies as we prepare to advance into phase 3 studies in ulcerative colitis and Crohn’s disease.”
In the ARTEMIS-UC phase 2 trial, a 12-week double-blind, placebo-controlled trial, patients with moderate to severely active UC who had failed conventional or advance therapy were assigned to either PRA023 (n=68) or placebo (n=67). According to topline results, 26.5% of patients given PRA023 reached the primary endpoint of clinical remission vs. 1.5% of patients on placebo at 12 weeks. Additionally, 36.8% on PRA023 reached endoscopic improvement vs. 6% on placebo.
The second phase 2 trial assessing PRA023, APOLLO-CD, was a 12-week open-label study of 55 patients with moderate-to-severely CD with endoscopically active disease who had failed conventional or biologic therapy. According to topline results, 26% of patients who received PRA023 achieved endoscopic response and 49.1% achieved clinical remission rates vs. prespecified historical placebo rates. PRA023 significantly reduced multiple inflammation and fibrosis markers, topline data showed.
In both studies, PRA023 was well tolerated, with no treatment-emergent serious adverse events or adverse events were reported. Of note, COVID-19 was the only adverse event reported a higher frequency in patients treated with PRA023 vs. placebo (5 vs. 3) in the ARTEMIS-UC trial.
“PRA023 has clearly demonstrated clinical proof-of-concept in CD and remarkable efficacy for the treatment of UC,” Allison Luo, MD, chief medical officer at Prometheus Biosciences, said in the release. “We are grateful to all of our investigators and patients for their participation and look forward to further evaluating PRA023 in phase 3 studies with the goal of bringing this promising candidate to the market.”
Based on these results, Prometheus intends to proceed with pivotal development for PRA023 in 2023. The company noted that the full data sets will be presented during an upcoming medical meeting.
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