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Phase 2 bowel disease data fire Prometheus' stock up 170% and set bar for Pfizer, Roivant

2022-12-07

临床2期临床结果临床3期

Data emboldened Prometheus Biosciences to set out plans to move PRA023 into phase 3.

Prometheus BioscPrometheus Biosciences major marker in the anti-PRA023pace. Days after Pfizer offloaded its rival candidate to Roivant, Prometheus has reported midphase data in ulcerative colitis and Crohn’s disease that sent its stock up 170% in premarket trading.

Prometheus Biosciencesulates the location and severity of inflamTL1Aon and fibrosis ledPfizerrchers to identify the protein as a way to Prometheusammatory bowel disease. Promethulcerative colitis leadCrohn’s disease validate that idea in the clinic. And, as the pair has moved in parallel toward midphase data, the biotech has maintained that its asset has an edge in terms of target engagement and bioavailability.

Now, PrometheuTL1As data to support its claims. The updateinflammationtrialfibrosisIS-UC in ulcerative colitis and APOLLO-CD in Crohn’s. Both inflammatory bowel diseaseenPrometheusd by Pfizerent that sent Prometheus’ stock spiraling upward.

In thPrometheusve colitis trial, 26.5% of recipients of the anti-TL1A antibody PRA023 went iulcerative colitission by Week 12 coCrohn’sto 1.5% of their peers on placebo. The study also met all of its rankePrometheusy goals, linking PRA023 to improvements in clinical, endoscopic, histologic and patient-reported outcome measures. Almost 37% of patients had endoscopic improvement, versus 6% in the placebo arm.

The Croulcerative colitisa control arm but provides early evidence that PRA023 PRA023prove outcomes in patients with endoscopically active disease failed by existing therapies. Around one-quarter, 26%, of patients had endoscopic resPRA023 and 49% entered clinical remission. Prometheus compared the data favorably to historical placebo endoscopic and clinical remission rates of 12% and 16%, respectively.

Exactly how good the results are will become clearer when Pfizer and RoiPRA023how their hand. Pfizer has completed the induction period of the midphase TUSCANY-2 study of its rival antibody PF-06480605 but is yet to share data. Roivant has formed a new subsidiary for furtherPrometheusnt of the Pfizer prospect.

Durability will be important for both programs, but for noPfizermetheRoivanted with its efficaPfizera and a fairly clean safety profile, can bask in the success of the induction studies. ShaPF-06480605biotech rose more than 200%Roivantnts during premarket trading. At the time of writing, the stPfizer up around 170% at close to $100.

The data emboldened Prometheus to set out plans to move PRA023 into phase 3 clinical trials in Crohn’s and ulcerative colitis next year following talks with regulators about the designs of the studies.

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机构

Prometheus