RED BANK, N.J., Sept. 30, 2020 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company
dedicated to intercepting and preventing immune-mediated disease,
today announced the submission of the clinical module of the
Company's Biologic License Application (BLA) to the U.S. Food and
Drug Administration (FDA) for teplizumab (PRV-031), an
investigational anti-CD3 monoclonal antibody for the delay or
prevention of clinical Type 1 Diabetes (T1D) in at-risk
individuals.
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A rolling submission allows for completed modules of the BLA to
be submitted to the FDA on an ongoing basis. Provention initiated
the rolling submission with the filing of the non-clinical module
in April 2020. The Company expects to
submit the final modules including the chemistry, manufacturing and
controls (CMC) module in Q4 2020. Once the complete BLA has been
submitted, the FDA will have 60 days to review the submission to
determine if it is complete. If deemed complete, the application
will be considered acceptable for review and the FDA will set a
PDUFA goal date.
"The filing of the BLA clinical module for teplizumab is a
critical step in our efforts to deliver teplizumab to
pre-symptomatic patients to delay or prevent insulin-dependent
T1D," said Dr. Eleanor (Leni)
Ramos, MD, CMO, Provention Bio. "I especially want to thank
Dr. Sharon Rowland, our SVP and Head
of Regulatory Affairs and the BLA clinical team who have worked
tirelessly for many months to achieve this goal. We look forward to
working closely with the FDA as we advance the regulatory process
and we remain on track to complete the full BLA submission in Q4
2020. In addition, we continue to scale our organization in
preparation for a potential commercial launch, and we are
well-positioned to execute our strategy to bring this
disease-modifying treatment to the T1D community as soon as
possible."
About Teplizumab (PRV-031):
Teplizumab is an anti-CD3 monoclonal antibody (mAb) being
developed for the interception, delay, or prevention of type 1
diabetes (T1D). More than 800 patients have received
teplizumab in multiple clinical studies involving more than 1,000
subjects. In previous studies of newly diagnosed patients,
teplizumab has consistently demonstrated the ability to preserve
beta-cell function, a measure of endogenous insulin production, and
correspondingly reduce the need for exogenous insulin use.
Teplizumab has been granted Breakthrough Therapy Designation by the
U.S. Food and Drug Administration (FDA) and PRIME designation by
the European Medicines Administration. Provention Bio has initiated
a rolling submission of the Biologic License Application for
teplizumab for the delay or prevention of insulin-dependent T1D for
use in presymptomatic patients and expects to complete the
submission in Q4 2020. Provention is currently evaluating
teplizumab in patients with newly diagnosed insulin-dependent T1D
(the Phase 3 PROTECT Study).
About Provention Bio, Inc.:
Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical
company leveraging a transformational drug development strategy
focused on the prevention or interception of immune-mediated
disease. Provention's mission is to source, transform and develop
therapeutic candidates targeting the high morbidity, mortality and
escalating costs of autoimmune diseases. Provention's diversified
portfolio includes teplizumab, a clinical-stage candidate that has
been shown in a clinical study to delay the onset of
insulin-dependent type 1 diabetes (T1D) in at-risk patients during
the presymptomatic phase of the disease as compared to placebo. The
Company's portfolio includes additional clinical product
development candidates that have demonstrated in pre-clinical
or clinical studies proof-of-mechanism and/or proof-of-concept
in other autoimmune diseases, including celiac disease and
lupus.
Forward Looking Statements:
Certain statements in this press release are forward-looking,
including but not limited to, statements relating to the Company's
planned submissions and timelines for the rolling BLA submission
for teplizumab and the potential health benefits of, and
commercialization efforts for teplizumab. 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 delays in, or failure to obtain FDA
approvals or clearances and noncompliance with FDA regulations; the
potential impacts of COVID-19 on our business and financial
results; changes in law, regulations, or interpretations and
enforcement of regulatory guidance; uncertainties of patent
protection and litigation; 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, 2019, our quarterly reports on
form 10-Q, and any subsequent filings with the Securities and
Exchange Commission. 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.
Investor Contact:
Sam
Martin, Argot Partners
sam@argotpartners.com
212-600-1902
Media:
Lori Rosen, LDR Communications
lori@ldrcommunications.com
917-553-6808
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SOURCE Provention Bio, Inc.