OLDWICK, N.J., April 24, 2019 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical
company dedicated to intercepting and preventing immune-mediated
diseases, today announced that it has completed the enrollment in
its Phase 2a PRINCE (PRovention Investigation in Crohn's DiseasE)
clinical trial evaluating PRV-6527 in patients with
moderate-to-severe Crohn's disease. PRV-6527 is an oral Colony
Stimulating Factor-1 Receptor (CSF-1R) small molecule
inhibitor.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
"The on-schedule completion of enrollment in the PRINCE study
for PRV-6527 is yet another significant executional achievement and
operational milestone in our mission to develop therapeutics that
intercept or prevent immune-mediated diseases," said Ashleigh
Palmer, CEO of Provention Bio. "In prior studies, PRV-6527
demonstrated proof of mechanism with evidence of tolerability and
favorable 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. We look forward to reporting
top-line data in the fourth quarter of 2019."
The Phase 2a PRINCE study is evaluating PRV-6527's ability to
intercept the differentiation of inflammatory dendritic cells and
macrophages, preventing their action in the intestinal mucosa in
Crohn's disease. The study enrolled 93 moderate-to-severe
Crohn's disease patients who were either naïve to biologic therapy
or who had previously failed at least one biologic drug. PRINCE is
a randomized, double-blind and placebo-controlled study evaluating
twice-daily dosing of PRV-6527 for 12 weeks. The primary endpoint
will assess clinical effect as measured by the Crohn's Disease
Activity Index (CDAI) score at week 12. Secondary efficacy
assessments include mucosal endoscopy, tissue histology and
analysis of other biomarkers including gene signature in colonic
tissue.
About PRV-6527
PRV-6527 is a highly potent and selective small-molecule oral
inhibitor of CSF-1R. It was developed by Janssen Pharmaceuticals
and has been evaluated in over 200 subjects to date. Proof of
mechanism was demonstrated based on inhibition of CSF-1R signaling
and myeloid cell counts in blood. CSF-1 binds to its receptor
(CSF-1R) on myeloid cells and drives the differentiation and
maturation of these cells into inflammatory dendritic cells and
macrophages, which then populate the gut and other tissues. In the
gut, these differentiated myeloid cells present antigens from
intestinal bacteria (the microbiome) to white blood cells and
trigger inflammatory processes. It is anticipated that significant
clinical benefits, such as preventing the relapse or progression of
Crohn's disease, as well as durable benefit which may result from
targeting the upstream pathologic mechanism, since
antigen-presenting cells are the necessary initiators of the
abnormal immune response.
About Crohn's Disease
Crohn's disease is a chronic, immune-mediated inflammatory bowel
disease (IBD) characterized by inflammation of the gastrointestinal
(GI) tract. Myeloid cells, a species of antigen-presenting
cells, are believed to play a central role in Crohn's disease by
presenting microbiome antigens to white blood cells in the gut.
CSF-1R drives myeloid cell differentiation in the bone marrow
resulting in the maturation of inflammatory dendritic cells and
macrophages, which then populate the gut and other tissues and
trigger inflammatory processes.
About Provention Bio, Inc.
Provention Bio, Inc. (Nasdaq: PRVB) is a clinical-stage
biopharmaceutical company leveraging a transformational drug
development strategy that is focused on the prevention or
interception of immune-mediated disease. Provention's mission
is to in-license, transform and develop therapeutic candidates
targeting the high morbidity, mortality and escalating costs of
autoimmune and inflammatory diseases including: type 1 diabetes
(T1D), Crohn's disease, ulcerative colitis, celiac disease, lupus,
and certain life-threatening viral diseases. Provention's
diversified portfolio includes advanced-stage product development
candidates that have undergone clinical testing by other companies.
For more information on Provention Bio, please
visit www.proventionbio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements may be identified by the use of
forward-looking words such as "anticipate," "believe," "forecast,"
"estimate," "expect," and "intend," among others. These
forward-looking statements are based on Provention's current
expectations and actual results could differ materially. There are
a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements.
These factors include, but are not limited to, risks related to
failure to obtain FDA approvals or clearances and noncompliance
with FDA regulations; uncertainties of patent protection and
litigation; limited research and development efforts and dependence
upon third parties; substantial competition; our need for
additional financing and the risks listed under "Risk factors" in
our annual report on Form 10-K for the year ended December 31,
2018 and any subsequent filings with the Securities and
Exchange Commission (SEC). As with any pharmaceutical under
development, there are significant risks in the development,
regulatory approval and commercialization of new products.
Provention does not undertake an obligation to update or revise any
forward-looking statement. The information set forth herein speaks
only as of the date hereof.
Investors:
Kimberly Minarovich or Sam Martin, Argot Partners
Kimberly@argotpartners.com or Sam@argotpartners.com
212-600-1902
Media:
David Rosen, Argot Partners
David.Rosen@argotpartners.com
212-600-1902
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SOURCE Provention Bio, Inc.