Provention Bio announces results from Phase 2a PRINCE clinical trial
Provention Bio announced top-line results from its randomized, placebo-controlled Phase 2a PRINCE clinical trial evaluating twice-daily PRV-6527, an oral Colony Stimulating Factor-1 Receptor, or CSF-1R, small molecule inhibitor. The PRINCE study enrolled 93 moderate-to-severe Crohn's disease patients who were either naive to biologic therapy, ~70%, or who had previously failed at least one biologic drug, ~30%. The primary efficacy endpoint of the study was the change in the Crohn's Disease Activity Index, or CDAI, score at week 12. While PRV-6527 demonstrated a substantial improvement in this symptom driven score at week 12, it did not differentiate from placebo. This high placebo response is deemed to be related to the background medication used, ~85%, in the study's predominantly biologic-naive population. RV-6527 was associated with improvements in several key secondary objective endpoints in the steroid-free population, including mucosal endoscopy and tissue histology. PRV-6527 was found to be generally safe and well tolerated, with no drug-related serious adverse events.