OLDWICK, N.J., May 8, 2019 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical company
dedicated to intercepting and preventing immune-mediated diseases,
today announced preliminary top-line results from its Phase
1b PULSE study which evaluated
PRV-300, an anti-TLR3 (toll-like receptor 3) monoclonal antibody,
in patients with active, moderate-to-severe ulcerative colitis
(UC).
PRV-300 met the primary safety and tolerability endpoint over
the twelve-week study period and also demonstrated TLR3 target
engagement and proof-of-mechanism. However, improvements in
secondary and exploratory clinical, endoscopic, histologic and
other UC-related efficacy endpoints were not observed over
background medication, suggesting that elevated TLR3 gene
signatures previously observed in UC patients, as well as in
PULSE, are downstream or circumstantial effects that do not
contribute significantly to causal pathology.
"I would like to thank the PULSE study patients, coordinators
and investigators, as well as Provention's expert clinical
development team, for their time, efforts, and dedication in
conducting such a definitive, cost-effective, and efficient
clinical trial," said Ashleigh Palmer, CEO of Provention Bio.
"The PULSE study, which enrolled 37 patients at three sites in just
seven months, exemplifies how Provention can rapidly determine
go/no-go decisions regarding the further development of therapeutic
candidates with the potential to intercept immune-mediated
diseases. PRV-300 did not demonstrate an upstream effect on
clinically relevant parameters in UC, but its favorable safety and
tolerability profile, and demonstration of proof-of-mechanism, may
offer an opportunity to sub-license this asset for evaluation in
other indications, including severe influenza and emerging viral
diseases, where an anti-TLR3 antibody has been successful in
preventing the release of toxic inflammatory mediators in animal
models."
About PULSE
The Phase 1b PULSE (Provention
ULcerative colitis Safety/PK/PD Evaluation) clinical trial was a
randomized, double-blind, placebo-controlled, parallel-group,
multicenter study that evaluated PRV-300 in 28 active, and 9
placebo, adult patients with moderate-to-severe ulcerative colitis.
All patients enrolled were naïve to other biologics and received
PRV-300 treatment intravenous infusion over 12-weeks followed by an
8-week safety follow-up period. The primary endpoint of PULSE
was to evaluate the safety and tolerability of PRV-300. Secondary
endpoints measured included PK and immunogenicity, mucosal healing,
tissue improvement and a biopsy-based mucosal mRNA signature.
Secondary and exploratory endpoints showed improvement in clinical,
endoscopic, histologic and gene disease scores at week 12 vs
baseline; however, these improvements were similar in both active
and placebo arms.
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, 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
View original content to download
multimedia:http://www.prnewswire.com/news-releases/provention-bio-announces-top-line-results-from-its-phase-1b-pulse-clinical-trial-of-prv-300-in-patients-with-moderate-to-severe-ulcerative-colitis-300846570.html
SOURCE Provention Bio, Inc.