OLDWICK, N.J., Feb. 6, 2020 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical company
dedicated to intercepting and preventing immune-mediated diseases,
today highlighted several new research studies on the increasing
prevalence of type one diabetes (T1D) and the importance of
screening for this life-impacting and life-threatening autoimmune
disease.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
The JDRF T1D Fund, JDRF, and Health Advances recently published
a white paper titled "Modeling the Total Economic Value of Novel
Type 1 Diabetes (T1D) Therapeutic Concepts" which
estimates there are 18 million people living with clinically
diagnosed Stage 3 T1D globally, and an additional 2.3 million with
pre-symptomatic Stage 1 and Stage 2 T1D, including at least 300,000
in the United States. The research
examines both the direct and the indirect costs, such as
productivity loss, associated with the economic burden of T1D. It
suggests $30 billion in annual costs
in the United States, less than
40% of which are attributed to direct medical costs and healthcare
services. Additionally, they conclude that while sustainable
"cures" could alleviate the $30
billion economic burden in the
United States; in the interim, disease modifying therapies
close to the clinic can bring more than $3
billion in value annually. Pre-symptomatic Stage 1 and Stage
2 T1D, which are evidenced by the presence of multiple islet
autoantibodies and autoimmune destruction of the insulin-producing
beta cells of the pancreas, indicates that the individual is on the
path to be diagnosed with clinical, insulin-dependent Stage 3
T1D.
A separate study published in the Journal of the American
Medical Association, titled "Yield of a Public Health Screening
of Children for Islet Autoantibodies in Bavaria, Germany", highlighted the importance of
screening for T1D and the significant reduction in diabetic
ketoacidosis (DKA) resulting from screening. The study, conducted
by Dr. Anette-Gabriele Ziegler of
the Institute of Diabetes Research, suggests that public health
screening for T1D in pre-symptomatic stages may reduce disease
burden and severity, as well as enable disease interception
strategies with novel agents.
"We commend the T1D Fund, JDRF, Dr. Ziegler and all of the
individuals involved in conducting important research that advances
the field of T1D," stated Ashleigh
Palmer, CEO of Provention Bio. "Experts increasingly agree
that the key to impacting the current trajectory of T1D is to
screen for individuals with early stages of T1D, at-risk of
developing clinical T1D, so that the disease could be prevented or
delayed. At a minimum, early identification of patients with Stage
1 and Stage 2 T1D will reduce life-threatening DKA."
Mr. Palmer continued, "We are working diligently to develop
teplizumab, which showed in a prior study that a single 14-day
course of therapy, delays the onset of insulin-dependent Stage 3
T1D in at-risk individuals by a median of at least two
years1. We are on track to submit a biologics license
application (BLA) for teplizumab in the fourth quarter of this
year. If approved, we believe teplizumab will be the first disease
modifying drug approved for T1D since insulin therapy was first
introduced in 1922."
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
1 Herold KC et al. An Anti-CD3 Antibody,
Teplizumab, in Relatives at Risk for Type 1 Diabetes. N
Engl J Med Aug 15 2019;
381:603-613
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SOURCE Provention Bio, Inc.