Provention Bio’s Crohn’s Disease Trial is Fully Enrolled, with Top-line Results Expected Later in Year

Provention Bio’s Crohn’s Disease Trial is Fully Enrolled, with Top-line Results Expected Later in Year
Provention Bio has completed patient enrollment for a Phase 2a clinical trial evaluating the efficacy and safety of its investigational oral therapy — PRV-6527 — for moderate to severe Crohn's disease, and plans to report its first top-line results in the fourth quarter of this year. The company believes the small molecule inhibitor will prevent disease flares (relapses) or disease progression, with longer-term effects, by blocking the first steps of the inflammatory process from happening in the gut, according to a press release. The Phase 2a PRINCE (PRovention Investigation in Crohn's DiseasE) clinical trial (NCT03854305) is a proof-of-concept study to evaluate PRV-6527’s anti-inflammatory benefit, both in terms of clinical manifestations and gut tissue inflammation, after 12 weeks of treatment. Enrollment took place in several European countries and Russia, recruiting 93 patients with moderate-to-severe active Crohn's disease who never received a biologic medication or who failed at least one biologic treatment. Patients will be randomly assigned to either oral PRV-6527 or a placebo, given twice daily over 12 weeks, followed by a four-week safety follow-up period. The treatment's effects will be primarily assessed by comparing the Crohn's Disease Activity Index (CDAI) score at the study start, and at treatment's end — at week 12 — in both groups. Other secondary assessments of effectiveness will include endoscopy, intestinal biopsies, histological examination, and analysis of other biomarkers, including genetic markers. PRV-6527, previously known as JNJ-40346527, is an oral, small-molecule inhibitor of colony stimulating factor-1 (CSF-1) receptor.  CSF-1 is a signaling protein, or cytokine — small secreted proteins released by c
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