OLDWICK, N.J., June 15, 2020 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today
announced extended follow-up data showing a single 14-day course of
teplizumab (PRV-031) significantly delayed the onset of
insulin-dependent type 1 diabetes (T1D) in presymptomatic patients
by a median of approximately three years compared to placebo. These
new data from the pivotal "At-Risk" TN-10 Study add one year to the
two-year median delay that was previously reported in the New
England Journal of Medicine and presented at last year's American
Diabetes Association's (ADA's) Scientific Sessions. Teplizumab,
Provention's lead drug candidate, is an anti-CD3 monoclonal
antibody in development for the delay or prevention of
insulin-dependent T1D in presymptomatic patients, defined by the
presence of two or more T1D-related autoantibodies and
dysglycemia.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
The study was conducted by TrialNet, a network of the world's
leading T1D researchers, and funded by the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK). The
findings were presented today at the ADA's 80th Scientific
Sessions.
"Continuing to delay the onset of clinical-stage T1D with just a
single course of teplizumab, now by approximately three years as
compared to placebo, is profoundly relevant for patients facing a
lifetime of insulin dependency, glucose monitoring, and lifestyle
challenges to survive," said Ashleigh
Palmer, CEO of Provention Bio. "We understand the urgency in
fundamentally changing the progression of T1D in early-stage
disease - before clinically relevant beta cell loss occurs - and
remain steadfast in our commitment to bring teplizumab to the T1D
community as quickly as possible."
Additional findings show C-peptide levels, a measure of a
person's own insulin production, decreased in the placebo group,
underscoring the destruction in beta cells that characterizes this
disease. In contrast, teplizumab treatment stabilized and then
significantly reversed the decline of C-peptide levels, suggesting
a delay in the destruction of beta cells and restoration of insulin
production by dysfunctional beta cells. Importantly, even in those
who advanced to clinical-stage T1D, treatment with teplizumab
resulted in a slower decline in C-peptide levels compared to
placebo.
"C-peptide levels were stabilized and even improved with
teplizumab treatment. We are highly encouraged to see these results
that confirm beta cell function is being preserved and suggest that
available beta cell function is being restored," said Colin Dayan,
MA MBBS, FRCP, Ph.D., Professor of Clinical Diabetes and
Metabolism, Cardiff University School of Medicine, who was not
involved with the TN-10 study. "These data provide further evidence
that, as a disease-modifying immunotherapy, teplizumab appears to
be treating the root cause of T1D autoimmunity and provides
potential benefit across several stages of the disease."
Presentations Highlights
- The median time to clinical diagnosis of T1D after one course
of teplizumab was approximately five years (an improvement of one
year from previously published data) compared to approximately two
years for the placebo group (unchanged from previously published
data). Compared to placebo, teplizumab treatment resulted in a 54%
reduction in risk of progressing to insulin-dependent T1D (hazard
ratio 0.457, p=0.01). During this extended follow-up, nearly half
of those treated with teplizumab are estimated to be free of
clinical-stage disease at five years.
- Teplizumab treatment was associated with a greater on-study
C-peptide (p=0.009) compared to placebo. For both groups, C-peptide
mean slopes preceding study entry were similar and declining. In
the placebo group, this decline continued over the 6 months after
study entry. By contrast, the teplizumab-treated group showed an
increased C-peptide over this period (p=0.02 relative to study
entry).
- Teplizumab was well tolerated and the safety data is consistent
with previous analyses.
Mr. Palmer added, "We remain on track to complete the Biologics
License Application submission for teplizumab for the delay or
prevention of insulin-dependent T1D in presymptomatic patients to
the U.S. Food and Drug Administration (FDA) in the fourth quarter
of this year. We look forward to working with the FDA as we advance
the regulatory process under our Breakthrough Therapy
designation."
About the Pivotal "At-Risk" TN-10 Study:
The "At-Risk"
TN-10 Study, a pivotal Phase 2 clinical trial, evaluated teplizumab
for the delay of insulin-dependent type 1 diabetes (T1D) in
presymptomatic patients, defined by the presence of two or more
T1D-related autoantibodies and dysglycemia (abnormal glucose
metabolism). Seventy-six patients were enrolled ages 8 to 49, with
72% under the age of 18, and randomized to receive a single course
of either teplizumab or placebo. Patients were followed in a
blinded fashion until 40 of them developed clinical-stage T1D, and
then indefinitely after the analysis of the randomized period
data.
About Type 1 Diabetes (T1D):
Over 1.6 million Americans have type 1 diabetes (T1D), an
autoimmune disease caused by the destruction of beta cells. T1D
symptoms can take months or years to develop. The psychological
impact of T1D is hard to quantity, but a diagnosis is
life-altering, and regular monitoring and maintenance can be
extremely stressful. T1D typically takes more than a decade off a
person's life and life expectancy is reduced by 16 years on average
for people diagnosed with T1D before the age of 10. Insulin is the
current T1D treatment. It is necessary to keep patients alive, but
it is a constant effort for patients. No disease-modifying
treatments for T1D are currently available.
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 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 (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 pre-commercial-stage candidate that has been shown to
delay the onset of insulin-dependent type 1 diabetes (T1D) in
at-risk patients during the presymptomatic phase of the disease.
The Company's portfolio includes additional clinical 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. 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 and uncertainties surrounding the COVID-19
pandemic, including the impact to our clinical trial programs,
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:
Lori Rosen, LDR
Communications
lori@ldrcommunications.com
917-553-6808
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SOURCE Provention Bio, Inc.