Prometheus Biosciences Inc shares have rocketed more than 170% on positive results for its therapeutic candidate PRA023 in both its ARTEMIS-UC Phase 2 and APOLLO-CD Phase 2a studies.
Prometheus is developing PRA023, a monoclonal antibody against cytokine TL1A, for the treatment of immune-mediated diseases including ulcerative colitis (UC), Crohn’s disease (CD), and systemic sclerosis-associated interstitial lung disease.
In a statement, the company said its ARTEMIS-UC trial met the primary endpoint with 26.5% of patients on PRA023 achieving clinical remission compared to 1.5% of patients on placebo at Week 12, and its APOLLO-CD trial showed a 26% endoscopic response and 49.1% clinical remission rates.
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PRA023 demonstrated favorable safety and tolerability results across both studies with no safety signal identified, Prometheus said.
Prometheus CEO Mark McKenna said the company was beyond enthusiastic with these study results, with the performance of PRA023 in both UC and Crohn’s patients surpassing its expectations.
“We believe PRA023 and our precision medicine approach has the potential to change the paradigm of inflammatory bowel disease (IBD) treatment and we look forward to discussions with regulatory agencies as we prepare to advance into Phase 3 studies in UC and CD,” he said.
Prometheus stock was up 171% following the release of its clinical trial results, trading at about US$99.70 per share shortly before noon on Wednesday.
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