Prometheus Biosciences Posts Phase 1 Data On Lead Therapeutic Candidate

  • Prometheus Biosciences Inc RXDX has reported topline results from its Phase 1 trial of PRA023 in healthy volunteers.
  • PRA023 was well-tolerated, with no safety signal identified during the study. There were no infusion reactions nor drug-related extension in infusion time, at doses of up to 1000 mg delivered intravenously over 30 minutes.
  • One of the secondary outcomes for the trial was the rate of immunogenicity after single and multiple doses of PRA023, measured up to 14 and 18 weeks. 
  • Data demonstrated that over 20% of participants who received PRA023 developed anti-drug antibodies through the prolonged follow-up period. 
  • Immunogenicity had no apparent impact on safety outcomes, pharmacokinetics, and pharmacodynamic (PD) parameters.
  • PD analyses demonstrated robust target engagement. 
  • The Company continues to enroll patients in Phase 2a study in Crohn's disease and Phase 2 study in ulcerative colitis.
  • Topline data from both studies are expected in Q4 of 2022.
  • Prometheus has also broadened its pipeline by adding a third indication for PRA023, Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD).
  • Phase 2 trial is anticipated to start in Q1 of 2022.
  • Price Action: RXDX shares are up 4.45% at $31.25 during the premarket session on the last check Tuesday.
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