OLDWICK, N.J., Dec. 12, 2019 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical
company dedicated to intercepting and preventing immune-mediated
diseases, today announced that it completed a Type B
multidisciplinary meeting with the U.S. Food and Drug
Administration (FDA) to discuss the proposed contents of a
Biologics License Application (BLA) for PRV-031 (teplizumab) for
the prevention or delay of type 1 diabetes (T1D) in individuals
at-risk of developing T1D. Based on official FDA meeting
minutes, Provention continues to expect that it will commence a
rolling BLA submission for PRV-031 in the middle of 2020 and is
targeting completion of the submission in the fourth quarter of
2020. The Company does not anticipate the need to conduct any
additional clinical trials in the at-risk population prior to BLA
submission.
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"Our discussion with the FDA was extremely productive, and
reinforces our confidence in the strength of our existing clinical,
pre-clinical, and safety data packages and our ability to proceed
with our BLA submission as planned," stated Ashleigh Palmer, CEO, Provention Bio.
"Consistent with the advantages afforded to us by the Breakthrough
Therapy designation for PRV-031, our discussion with the FDA also
focused on how to facilitate a rolling submission of the various
BLA modules, including the chemistry, manufacturing and controls
(CMC) module. We are now focused on preparing the clinical
and pre-clinical modules for anticipated submission by the middle
of 2020. In parallel, we are undertaking necessary steps to
demonstrate comparability of to-be-commercialized material with
that previously used in clinical studies and, thereafter, expect to
submit our CMC module in the fourth quarter of 2020. We look
forward to continuing to work closely with the FDA as we prepare
our submission for this groundbreaking therapy."
For the CMC module, the FDA confirmed that it would require the
demonstration of comparability between the study drug previously
manufactured by MacroGenics and Eli Lilly and the
to-be-commercialized drug substance and drug product scheduled for
production by Provention and its contract manufacturing
partners.
The Type B meeting discussion with the FDA continues to support
Provention's belief that results from the "At-Risk" study, together
with adequate confirmatory evidence from prior teplizumab studies
in early onset T1D, will be sufficient for a BLA submission.
The FDA provided guidance on specific analyses of data from the
Company's clinical database of over 800 patients for inclusion in
the BLA submission, specifically the impact of PRV-031 on C-peptide
levels in T1D patients. C-peptide is a byproduct of endogenous
insulin production and a universally accepted measure of the amount
of insulin naturally produced by functional beta cells in the
pancreas.
The FDA also confirmed that the safety database from the "At
Risk" study and prior teplizumab clinical studies in patients with
early onset T1D appears adequate to support the submission and
review of a BLA.
Conference Call and Webcast Information
Provention
Bio will discuss the PRV-031 regulatory update via conference call
today, Thursday, December 12, 2019 at 8:30 am ET. A
webcast presentation will also be available on the Investors page
of the Company's website, www.proventionbio.com. To
access the call, please dial 1-877-870-4263 (domestic) or
1-412-317-0790 (international) five minutes prior to the start time
and ask to be connected to the "Provention Bio Call". A webcast
replay of the call will be available beginning
at approximately 10:30 am ET on the day of the
call.
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), 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, including statements
related to timing of submission of the BLA. 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.