OLDWICK, N.J., Oct. 24, 2019 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical
company dedicated to intercepting and preventing immune-mediated
diseases, today announced the European Medicines Agency (EMA) has
granted PRV-031 (teplizumab) PRIority MEdicines (PRIME) designation
for the prevention or delay of clinical type 1 diabetes (T1D) in
individuals at-risk of developing the disease.
PRIME designation is awarded by the EMA to promising medicines
that demonstrate the potential to address substantial unmet medical
need based on clinical data. The EMA considers PRIME
designations a priority and provides them with special support,
including enhanced interactions and dialogue, as well as a pathway
for accelerated evaluation and review.
"We are very pleased the EMA recognizes the transformative
potential of PRV-031 and has granted this groundbreaking therapy
PRIME designation", said Ashleigh Palmer CEO, Provention Bio.
"Following on the heels of Breakthrough Therapy Designation from
the FDA in August, EMA PRIME further
validates the rationale for PRV-031 to prevent or delay the onset
of clinical T1D in at-risk subjects. We are committed to working
closely with both regulatory agencies to bring PRV-031, as quickly
as possible, to the many thousands of T1D at-risk individuals who
currently have no options to prevent or delay this catastrophic
disease."
PRV-031's PRIME designation was based on clinical data from the
"At-Risk" Study conducted by TrialNet, which demonstrated
that a single 14-day course of PRV-031 significantly delayed the
onset of T1D, as compared to placebo, by a clinically-relevant
median of at least 2 years in children and adults at high risk of
developing clinical T1D.
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.
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
212-600-1902
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SOURCE Provention Bio, Inc.