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.