Biopharmaceutical firm Provention Bio has concluded patient enrolment in the Phase IIa PRINCE clinical trial of PRV-6527 for the treatment of patients with moderate-to-severe Crohn's disease.
The trial recruited 93 subjects who did not undergo prior biologic therapy or previously experienced inadequate response to at least one biologic drug.
Developed by Janssen Pharmaceuticals, PRV-6527 is an oral, selective small molecule inhibitor of Colony Stimulating Factor-1 Receptor (CSF-1R). Provention Bio licensed the compound from Janssen in 2017.
Crohn's disease is an immune-mediated inflammatory bowel disease (IBD), which is believed to be driven by myeloid cells.
CSF-1R plays a key role in myeloid cell differentiation in the bone marrow that could trigger inflammatory processes in the gut.
Targeting the receptor is expected to yield significant clinical benefits, including prevention of the relapse or progression of Crohn's disease.
The PRINCE trial is designed to assess PRV-6527's ability to block the differentiation of inflammatory dendritic cells and macrophages, which are formed from myeloid cells, in order to prevent disease-related affects in the intestinal mucosa.
A twice-daily dose of the drug candidate will be monitored over 12 weeks.
The primary endpoint of the randomised, double-blind and placebo-controlled trial is clinical effect as measured using the Crohn's Disease Activity Index (CDAI) score at week 12.
In addition, the study will assess secondary efficacy objectives such as mucosal endoscopy, tissue histology, and analysis of other biomarkers including gene signature in colonic tissue.
Provention Bio CEO Ashleigh Palmer said: “In prior studies, PRV-6527 demonstrated proof of mechanism with evidence of tolerability and favourable pharmacology.
“The results from the PRINCE study may establish the potential of this oral candidate in Crohn's disease, an indication which is currently dominated by biologics that offer limited benefit over the long-term.”
Top-line results from the trial are expected to be available in the fourth quarter of this year.