OLDWICK, N.J., Oct. 23, 2018 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a clinical-stage biopharmaceutical company
focused on immune-mediated diseases, announced today that it has
completed enrollment in the Phase 1b
clinical trial of PRV-300 in patients with moderate-to-severe
ulcerative colitis (UC). Provention is developing PRV-300, an
anti-TLR3 monoclonal antibody, to intercept upstream disease
processes in UC patients.
"Completion of enrollment of our Phase 1b clinical trial of PRV-300 in ulcerative
colitis is an important operational milestone for Provention," said
Ashleigh Palmer, co-founder and CEO
of Provention Bio, Inc. "The relative speed, efficiency and agility
by which we were able to design, initiate and complete enrollment
of this study demonstrates some of Provention's core capabilities
that underpin our transformational drug development strategy to
reposition and advance candidates that have been underdeveloped or
deprioritized, yet have human data indicating the potential to
prevent or intercept immune-mediated disease."
The Phase 1b clinical trial of
PRV-300 (Provention Ulcerative colitis Safety,
pharmacokinetic and pharmacodynamic Evaluation or PULSE) was
initiated in the first quarter of 2018 following the in-licensing
of the drug from Janssen in the second quarter of 2017. The
trial completed the planned target enrollment of 36 patients with
moderate-to-severe UC. The primary endpoint of the study is
safety, with secondary endpoints designed to evaluate the effect of
PRV-300 on endoscopic and histologic endpoints, and a biopsy-based
mucosal gene expression signature. These criteria are intended
to determine proof-of-mechanism and, potentially, proof-of-concept,
allowing Provention to potentially advance directly to Phase
2b. Top-line data from PULSE is
expected in the second quarter of 2019.
About PRV-300
PRV-300 (previously known as JNJ-42915925) is a first-in-class,
fully human, IgG4κ monoclonal antibody (mAb) that binds the
extracellular domain of TLR3 with high specificity and
affinity. Toll-like receptors (TLRs) are sensor molecules of
the innate immune system, which detect certain microbial pathogens
and initiate protective immune responses. There is increasing
evidence that TLR3 plays an important role in the pathologic
response to emerging viral infections and the excessive immune
reactions they can trigger. TLR3 has also been implicated in
chronic pathologic inflammation triggered by non-viral RNA. This
appears to be the case in inflammatory disorders such as UC.
Provention believes the blockade of TLR3 by PRV-300 may provide an
effective therapy to intercept the upstream stages in the
pathophysiology of UC and potentially prevent relapse or
exacerbation.
About Ulcerative Colitis
Ulcerative colitis is the
most common form of inflammatory bowel disease (IBD). It is a
"relapsing-remitting" disease with chronic destructive inflammation
and epithelial injury in the gastrointestinal tract. There is
considerable morbidity associated with UC, which often leads to
surgical removal of the colon and a severely reduced quality of
life. Substantial unmet medical needs and suffering remain despite
current anti-inflammatory and immune suppressive therapeutics.
About Provention Bio, Inc.
Provention Bio, Inc. 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 diverse portfolio was assembled with
product candidates that have undergone clinical testing but may
have been underdeveloped or deprioritized assets at other
companies. Provention's mission is to in-license, transform and
develop clinical-stage, or nearly clinical-stage, 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, lupus, and
certain life-threating viral diseases. 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 factors listed under
"Risk Factors" in our quarterly report on Form 10-Q for the quarter
ended June 30, 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.
Media & Investor Contacts
Jason Rando / Joshua
Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
T: 212 375 2665 / 212 375 2664
jrando@tiberend.com
jdrumm@tiberend.com
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SOURCE Provention Bio, Inc.