Provention Bio Says Crohn's Disease Treatment Misses Primary Endpoint

By Chris Wack

Provention Bio Inc. (PRVB) said top-line results from its Phase 2a Prince clinical trial for its PRV-6527, an oral Colony Stimulating Factor-1 Receptor small molecule inhibitor, didn't achieve its primary endpoint.

The biopharmaceutical company said the Prince study, which enrolled 93 moderate-to-severe Crohn's disease patients, didn't differentiate PRV-6527 from the placebo.

Provention Bio said PRV-6527 was associated with improvements in several key secondary objective endpoints in the steroid-free population, including mucosal endoscopy and tissue histology.

The company said analysis of exploratory serum and tissue biomarkers showed that patients treated with PRV-6527 had significant reductions in circulatory inflammatory monocytes, as well as macrophages, dendritic cells and the CSF1 gene signature in colonic tissue, providing proof of mechanism in the interception of inflammatory myeloid cells. PRV-6527 was found to be generally safe and well tolerated, with no drug-related serious adverse events.

Provention said that under the terms of an in-license agreement, Janssen Pharmaceuticals now has 90 days to exercise its option to re-acquire the asset to support further development in inflammatory bowel disease.

Pursuant to its licensing agreement with Provention, Janssen has the right to buy back PRV-6527 for a one-time payment of $50 million and single-digit royalties on future net sales. If Janssen doesn't take back PRV-6527, Provention is free to sublicence the program on a worldwide basis to another partner in the field of inflammatory bowel disease.

Shares of Provention Bio were down 11% to $5.43 in light premarket trading.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

October 22, 2019 07:42 ET (11:42 GMT)

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