OLDWICK, N.J., March 16, 2020 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical company
dedicated to intercepting and preventing immune-mediated diseases,
today announced a temporary pause in the randomization of patients
with newly diagnosed type 1 diabetes (T1D) into its global Phase 3
PROTECT study of PRV-031 (teplizumab). This pause is being taken
out of an abundance of caution to protect patients, caregivers,
clinical site staff, company employees and contractors at this
critical juncture in the collective global efforts to combat the
COVID-19 pandemic. Patients currently undergoing study therapy will
be allowed to complete their course, as recommended by the PROTECT
study's Data Safety Monitoring Board, which was recently expanded
to include infectious diseases expertise. The Company remains on
track to complete its rolling submission of a Biologics License
Application (BLA) to the U.S. Food and Drug Administration (FDA)
for teplizumab for the prevention or delay of T1D in at-risk
individuals in the fourth quarter of 2020.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
"Our decision to pause randomization of new patients into the
PROTECT study follows COVID-19-related State of Emergency
declarations in many countries where our study is taking place,
including the United States," said
Ashleigh Palmer, CEO of Provention
Bio. "Our decision was not based on any study-related COVID-19
infections or other safety events, but rather a preponderance of
caution relating to the ongoing pandemic, and our concern for the
well-being of recently diagnosed T1D pediatric patients and their
caregivers. The demands on medical institutions and their
clinicians during this unprecedented global crisis were also a main
consideration in this decision. For avoidance of any doubt, we
believe teplizumab will prove to be a well-tolerated therapy with a
favorable safety profile as evidenced by our database of more than
800 patients. We will continue to monitor the situation closely and
will provide an updated timeline for the PROTECT study at a future
date."
Provention remains on track to complete its rolling BLA
submission for teplizumab in T1D patients at-risk of developing
clinical stage disease in the fourth quarter of 2020. As Provention
has stated previously, the critical path to completion of the
rolling BLA submission will be the filing of the chemistry,
manufacturing and controls (CMC) module. The Company continues to
expect to proceed with three commercial scale process performance
qualification (PPQ) batches this summer, supporting the CMC module
and enabling the completion of the rolling BLA submission as
planned. The Company has not experienced any interruption in its
supply chain or manufacturing efforts at this time.
As of this date, none of the Company's other clinical and
pre-clinical operations have been significantly impacted by the
COVID-19 Public Health Crisis.
PROTECT Phase 3 Trial
The global PROTECT (PROvention T1D trial Evaluating C-peptide
with Teplizumab) Phase 3 clinical trial is a randomized,
double‑blind, placebo-controlled, multicenter trial that is
expected to enroll approximately 300 patients ages 8-17 with recent
onset T1D at approximately 90 centers worldwide. The patients will
be randomized 2:1 to either two 12-day cycles, six months apart, of
intravenous PRV-031 (teplizumab) or placebo. The primary efficacy
endpoint is C-peptide change. Secondary endpoints include insulin
use, HbA1c, hypoglycemic episodes, and safety.
Additional information is available
at clinicaltrials.gov.
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. Teplizumab has been shown to delay the onset of
end-stage T1D in at-risk individuals with pre-symptomatic
disease. 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. Teplizumab has been granted Breakthrough Therapy designation
from the U.S. Food and Drug Administration. Provention
is currently evaluating PRV-031 in patients newly diagnosed with
clinical 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. Teplizumab has been granted
Breakthrough Therapy designation from the U.S. Food and Drug
Administration. 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 the length of the
temporary pause in the Phase 3 PROTECT study of PRV-031 and the
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.