OLDWICK, N.J., Aug. 5, 2019 /PRNewswire/ -- Provention Bio, Inc.
(Nasdaq:PRVB), a clinical stage biopharmaceutical company dedicated
to intercepting and preventing immune-mediated disease, today
announced that the U.S. Food and Drug Administration (FDA) has
granted Breakthrough Therapy Designation (BTD) to teplizumab
(PRV-031) for the prevention or delay of clinical type 1 diabetes
(T1D) in individuals at-risk of developing the disease.
BTD is an FDA program designed to expedite the development and
review of therapeutic candidates intended to treat serious or
life-threatening diseases. To qualify for this designation,
preliminary clinical evidence has to indicate that the drug may
demonstrate substantial improvement over available therapy on a
clinically significant endpoint. The benefits to Provention of this
BTD include more intensive and interactive guidance from FDA on an
efficient drug development program, access to a scientific liaison
to help expedite review time, and eligibility for Priority Review
if relevant criteria are met.
The FDA decision on BTD was based on clinical data from the
"At-Risk" Study conducted by TrialNet, which showed that a single
14-day course of PRV-031 (teplizumab) significantly delayed the
onset and diagnosis of clinical T1D, as compared to placebo, by a
median of at least 2 years in children and adults considered to be
at high risk of developing clinical T1D.
"We are pleased that the FDA recognizes the transformative
potential of PRV-031 in T1D, and we are committed to working with
the Agency to bring this candidate to patients as quickly as
possible," stated Ashleigh Palmer,
CEO of Provention Bio. "The groundbreaking data from the 'At Risk'
trial showed, for the first time, the potential to delay the onset
of T1D in individuals who are almost certain to develop clinical
disease. With this designation in place, we plan to leverage
that landmark data, as well as the robust safety database from
prior teplizumab studies, to support a registration filing.
We look forward to discussing next steps with the FDA and providing
an update on the process in the coming months."
About PRV-031 (teplizumab)
PRV-031, also known as teplizumab, is an anti-CD3 monoclonal
antibody (mAb), which is being developed for the interception and
prevention of type 1 diabetes (T1D). The candidate has been
the subject of multiple clinical studies involving more than 1,000
subjects with more than 800 patients receiving PRV-031 in those
studies. In previous studies of newly diagnosed patients,
PRV-031 has consistently demonstrated the capability of preserving
beta cell function and reducing the need for exogenous insulin
usage. Provention is currently evaluating PRV-031 in patients newly
diagnosed with clinical T1D (the Phase 3 PROTECT Study); additional
information on the clinical trial is available at
www.clinicaltrials.gov.
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, and lupus. 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:
Sam Martin, Argot Partners
sam@argotpartners.com
212-600-1902
Media:
David Rosen, Argot Partners
david.rosen@argotpartners.com
856-630-0006
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SOURCE Provention Bio, Inc.