Provention Bio Says Crohn's Disease Treatment Misses Primary Endpoint
October 22 2019 - 07:57AM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
October 22, 2019 07:42 ET (11:42 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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