Prometheus Biosciences, Inc. (NASDAQ: RXDX) is engaged as a clinical-stage biotechnology company, which is focused on the research, development and commercialization of novel therapeutics for the treatment of immune-mediated diseases. Shares of the biotech company are skyrocketing 175% through early trading on Wednesday, December 7, 2022. Over the past three months, Prometheus Biosciences has seen average daily volume of 597,160 shares. However, volume of 6.14 million shares or dollar volume of around $610.56 million, has already exchanged hands through early trading.
Shares of Prometheus Biosciences are surging after the company announced positive results from its PRA023 drug candidate in recent clinical trials. PRA023 is a IgG1 humanized monoclonal antibody that has shown the ability to block tumor necrosis factor (TNF)-like ligand 1A (TL1A). This could help provide potentially-substantial improvements for patients suffering from moderate-to-severe irritable bowel disease (IBD).
PRA023 recently underwent a successful ARTEMIS-UC Phase 2 and APOLLO-CD Phase 2a clinical studies, which puts the drug candidate on the path to becoming both the first-in-class and the best-in-class treatment for Anti-TL1a mAb.
The Phase 2 ARTEMIS-UC trial was a 12-week, double-blind, placebo-controlled, randomized study that sought to test the efficacy and safety of PRA023 in patients suffering from moderate-to-severe active UC and have no responded to traditional treatments. The results showed 26.5% of patients being treated with PRA023 reached the primary endpoint of clinical remission, compared to only 1.5% in the placebo group. Furthermore, 36.8% of PRA023 patients achieved their secondary endpoint of endoscopic improvements, compared to only 6% in the placebo group.
During the Phase 2a APOLLO-CD trial, patients underwent a 12-week open-label study that enrolled 55 patients with moderate-to-severe active CD and have not responded to traditional treatments. The results showed 26% of patients on PRA023 saw a meaningful endoscopic response, compared to only 12% in the placebo group. In addition, 49.1% of patients taking the drug candidate achieved clinical remission compared to only 16% in the placebo group.
“PRA023 has clearly demonstrated clinical proof-of-concept in CD and remarkable efficacy for the treatment of UC,” added Allison Luo, MD, Chief Medical Officer. “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.”
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