Clinical-stage biotech company Prometheus Biosciences Inc. (RXDX:NASDAQ), which is engaged in the discovery, development, and commercialization of medicines for use in the treatment of immune-mediated diseases such as inflammatory bowel disease (IBD), today announced "results from its ARTEMIS-UC Phase 2 and APOLLO-CD Phase 2a studies of PRA023 demonstrating strong efficacy and favorable safety results in both studies."
The firm advised that based upon the data collected during both of these independent Phase 2 trials, it plans to initiate discussions with regulators to move forward with two additional Phase 3 studies of PRA023 in FY/23 for the treatment of Crohn's disease (CD) and ulcerative colitis (UC).
Prometheus advised that in its Phase 2 ARTEMIS-UC trial, "PRA023 met the primary and all ranked secondary endpoints including clinical, endoscopic, histologic, and patient-reported outcome measures in the initial cohort (Cohort 1) of the trial."
In the double-blind, randomized ARTEMIS-UC trial, 135 patients with moderate-to-severely active UC who did not respond to prior therapies were treated over a period of 12 weeks with either PRA023 or placebo. The topline data showed that 26.5% of patients on PRA023 successfully achieved the predetermined primary endpoint of clinical remission versus just 1.5% in the control group. Additionally, 36.8% of the patients who receive PRA023 met the key secondary endpoint of endoscopic improvement, compared to 6.0% for those who were administered a placebo.
RXDX shares opened almost 200% higher today at US$105.07 (+US$69.01, +191.38%) over yesterday's US$36.06 closing price and reached a new 52-week high price this morning of US$111.99.
The firm also reported positive findings in its Phase 2a APOLLO-CD trial, which enrolled a total of 55 patients diagnosed with a moderate-to-severely active CD with endoscopically active disease who also had failed other standard treatment regimens.
Results from the APOLLO-CD study demonstrated that 26.0% of patients who received PRA023 achieved endoscopic response versus the historical average placebo rate of 12%. In addition, 49.1% of trial participants' patients administered PRA023 achieved clinical remission, compared to the historical placebo group rate of 16%.
Prometheus Biosciences' Chairman and CEO Mark McKenna commented, "We are beyond enthusiastic with these study results and what they could mean for patients suffering from IBD. The performance of PRA023 in both UC and Crohn's patients has surpassed our expectations . . . We believe PRA023 and our precision medicine approach [have] 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."
The company's Chief Medical Officer Allison Luo, M.D. remarked, "PRA023 has clearly demonstrated clinical proof-of-concept in CD and remarkable efficacy for the treatment of UC . . . We look forward to further evaluating PRA023 in Phase 3 studies with the goal of bringing this promising candidate to the market."
The firm explained that "PRA023 is an IgG1 humanized monoclonal antibody that has been shown to block tumor necrosis factor (TNF)-like ligand 1A (TL1A)." The company indicated that PRA023 shows the potential to substantially improve outcomes for patients with moderate-to-severe IBD in those persons predisposed to increased TL1A expression. In addition to prospective uses in the treatment of UC and CD, Prometheus is also investigating and developing PRA023 for use in treating systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Prometheus Biosciences is a clinical-stage biotechnology firm based in San Diego, Calif., that is focused on discovering, developing, and commercializing novel therapeutics to treat immune-mediated diseases. The firm has created a precision medicine platform called Prometheus360™, which utilizes machine learning technology to query gastrointestinal bioinformatics databases to identify potential new therapeutic targets. The firm's activities were initially focused mostly on gastrointestinal (GI) diseases such as IBD, but it is now expanding its efforts to target other autoimmune diseases.
Prometheus Biosciences started off the day with a market cap of around US$1.51 billion, with approximately 41.94 million shares outstanding and a short interest of about 11.6%. RXDX shares opened almost 200% higher today at US$105.07 (+US$69.01, +191.38%) over yesterday's US$36.06 closing price and reached a new 52-week high price this morning of US$111.99. The stock has traded today between US$95.50 and US$111.99 per share and is currently trading at US$97.82 (+US$61.76, +171.27%).
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