OLDWICK, N.J., April 16, 2020 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a clinical-stage biopharmaceutical
company dedicated to intercepting and preventing immune-mediated
diseases, today announced the initiation of the rolling submission
of the Company's Biologic License Application (BLA) to the U.S.
Food and Drug Administration (FDA) for teplizumab (PRV-031), an
anti-CD3 monoclonal antibody for the delay or prevention of
clinical Type 1 Diabetes (T1D) in at-risk individuals, as indicated
by the presence of two or more T1D-related autoantibodies.
Rolling submission allows for completed modules of the BLA to be
submitted and reviewed by the FDA on an ongoing basis.
Provention submitted the non-clinical module and expects to submit
the clinical module in Q3 and the chemistry, manufacturing and
controls (CMC) module in Q4 of 2020. Once the final module of
the BLA has been submitted, FDA will make a filing decision and set
a PDUFA goal date.
"The initiation of our BLA submission process represents an
important milestone for Provention as we advance teplizumab toward
the market as the first-ever treatment for patients at-risk of
advancing to clinical type 1 diabetes," said Ashleigh Palmer, President & CEO of
Provention Bio. "The data from the 'At Risk' Study, published last
year, underscores the transformative therapeutic potential of
teplizumab to delay or prevent the onset of clinical-stage,
insulin-dependent, T1D. We remain on track to complete the
BLA submission by year-end and look forward to working with the FDA
as we advance the regulatory process."
In June 2019, data from the
At-Risk trial, sponsored by the National Institutes of Health and
conducted by TrialNet, was presented at the 79th Annual
American Diabetes Association meeting and published in the New
England Journal of Medicine. Results of this study demonstrated
that a single 14-day course of teplizumab significantly delayed the
onset of clinical-stage T1D, as compared to placebo, by a median of
at least 2 years in at-risk children and adults.
Teplizumab has received both Breakthrough Therapy Designation
from the FDA and PRIME designation from the European Medicines
Administration, allowing for greater dialogue and increased
likelihood of priority review and accelerated assessment by the two
agencies, respectively.
About teplizumab (PRV-031):
Teplizumab (PRV-031), is an anti-CD3 monoclonal antibody (mAb),
which is 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, PRV-031 has consistently demonstrated the capability of
preserving beta cell function and reducing the need for exogenous
insulin usage. PRV-031 has been granted Breakthrough Therapy
designation from the U.S. Food and Drug Administration and PRIME
designation by the European Medicines Administration.
Provention is currently evaluating PRV-031 in patients with newly
diagnosed clinical-stage T1D (the Phase 3 PROTECT Study).
About Provention Bio, Inc.:
Provention Bio, Inc. (Nasdaq: PRVB) is a clinical-stage
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 PRV-031 (teplizumab), a
pre-commercial-stage candidate that has been shown to delay the
onset of end-stage type one diabetes (T1D) in at-risk individuals
with pre-symptomatic disease. The Company's portfolio
includes additional clinical-stage product development candidates
that have demonstrated 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
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,
2019 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.