RED BANK, N.J., March 3, 2021 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today
announced that extended follow-up data from the pivotal "At-Risk"
TN-10 Study were published in Science Translational
Medicine. Results show that a single 14-day infusion course of
teplizumab (PRV-031) delayed the onset of clinical disease and
insulin dependence in at-risk type 1 diabetes (T1D) patients by
approximately three years (median of 32.5 months), adding one year
to previously reported results. The TN-10 Study was conducted
through the Type 1 Diabetes TrialNet, an international research
collaboration aimed at discovering ways to delay or prevent type 1
diabetes.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
Teplizumab, Provention's lead drug candidate, is an anti-CD3
monoclonal antibody currently under review by the U.S. Food and
Drug Administration (FDA) for the delay or prevention of clinical
T1D in at-risk individuals, defined as having two or more
T1D-related autoantibodies and dysglycemia (Stage 2 T1D). The
lifetime risk of insulin-dependent clinical disease (Stage 3 T1D)
approaches 100% in these pre-symptomatic Stage 2 patients.
"Teplizumab is the first disease-modifying investigational drug
with data showing an ongoing delay to insulin-dependent T1D, now by
approximately three years after a single course," said Dr.
Kevan Herold, M.D., Professor of
Immunology and Medicine at Yale
University, lead author of the study. "These data build on
existing clinical evidence demonstrating the potential for
teplizumab to change the course of the disease and advance the
treatment paradigm. We are continuing to observe patients in the
TN-10 Study to determine whether the observed delay will extend
even further over time."
The median time to clinical T1D was approximately 5 years in
teplizumab-treated patients compared to slightly over 2 years in
the placebo group. At this median follow-up of 2.5 years, twice as
many teplizumab-treated patients remained free of clinical T1D
compared to patients in the placebo group, 50% vs 22% respectively,
(HR=0.457 p=0.01).
"It is very encouraging to see that a single course of
teplizumab delayed insulin dependence in this high risk population
for approximately three years versus placebo," said Frank Martin, Ph.D., JDRF Director of Research.
"These exciting results have been made possible by the unwavering
efforts of TrialNet and Provention Bio. Teplizumab, if approved by
the FDA, could positively change the course of disease development
for people at risk of developing T1D and their standard of
care."
The following includes key additional data and analysis from the
publication:
- Teplizumab treatment improved beta cell function, with an
average on-study C-peptide AUC of 1.96 vs 1.68 pmol/ml,
p=0.006.
- Initiation of teplizumab treatment reversed the decline in
C-peptide levels while controls continued to decline (p=0.0015).
The changes in C-peptide with teplizumab treatment were associated
with increases in partially exhausted memory KLRG1+ TIGIT+ CD8+ T
cells (r=0.44; p=0.014) that showed reduced secretion of IFN-gamma
and TNF-alpha.
- Total and early insulin secretory capacity was improved with
teplizumab treatment suggesting improvement in beta cell glucose
sensitivity reflecting normal beta cell function.
- Teplizumab was well tolerated, and the safety data is
consistent with previous analyses.
"These data embolden our enthusiasm surrounding the potential
impact teplizumab may have on the lives of T1D patients, families
and caregivers," said Ashleigh
Palmer, CEO and Co-Founder, Provention Bio. "Outcomes such
as these validate Provention's mission to intercept and prevent
debilitating and life-threatening diseases. We continue
working closely with the FDA in their review of our BLA submission
for teplizumab. The PDUFA goal date is July
2, 2021."
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 (Stage 3 of
clinical T1D) in presymptomatic, Stage 2 or at-risk patients,
defined by the presence of two or more T1D-related autoantibodies
and dysglycemia. 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.
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) and JDRF. The
primary results were published in the New England Journal of
Medicine and simultaneously presented at the 2019 American Diabetes
Association's 79th Scientific Sessions.
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 investigational anti-CD3 monoclonal antibody (mAb)
with a filed Biologics License Application (BLA) under Priority
Review by the U.S. Food and Drug Administration (FDA) for the delay
or prevention of clinical type 1 diabetes (T1D) in at-risk
individuals. 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 consistently demonstrated the ability to preserve
beta-cell function, a measure of endogenous insulin production. It
correspondingly reduced the need for exogenous insulin use.
Teplizumab has been granted Breakthrough Therapy Designation by the
FDA and PRIME designation by the European Medicines Administration.
Provention is currently also evaluating teplizumab in patients with
newly diagnosed insulin-dependent T1D (the Phase 3 PROTECT
study).
About JDRF:
JDRF's mission is to accelerate
life-changing breakthroughs to cure, prevent, and treat T1D and its
complications. To accomplish this, JDRF has invested more than
$2.5 billion in research funding
since our inception. We are an organization built on a grassroots
model of people connecting in their local communities,
collaborating regionally for efficiency and broader fundraising
impact and uniting on a national stage to pool resources, passion
and energy. We collaborate with academic institutions, policymakers
and corporate and industry partners to develop and deliver a
pipeline of innovative therapies to people living with T1D. Our
staff and volunteers throughout the
United States and our five international affiliates are
dedicated to advocacy, community engagement and our vision of a
world without T1D. For more information, please visit jdrf.org or
follow us on Twitter: @JDRF.
About Provention Bio, Inc.:
Provention Bio, Inc.
(Nasdaq: PRVB) is a biopharmaceutical company focused on advancing
the development of investigational therapies that may intercept and
prevent debilitating and life-threatening immune-mediated diseases.
The Biologics License Application (BLA) for teplizumab, its lead
investigational drug candidate, for the delay or prevention of
clinical type 1 diabetes in at-risk individuals has been filed by
the U.S. Food and Drug Administration (FDA). The Company's pipeline
includes additional clinical-stage product 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. Visit www.ProventionBio.com for more
information and follow us on Twitter: @ProventionBio.
Internet Posting of Information:
Provention Bio, Inc. uses its website, www.proventionbio.com,
as a means of disclosing material nonpublic information and for
complying with its disclosure obligations under Regulation F.D.
Such disclosures will be included on the Company's website in the
"News" section. Accordingly, investors should monitor this portion
of the Company's website, in addition to following its press
releases, SEC filings and public conference calls and
webcasts.
Forward Looking Statements:
Certain statements in this press release are forward-looking,
including but not limited to, statements relating to regulatory
review of the BLA submission for teplizumab and the potential
approval and commercial launch of teplizumab, including timelines
relating to the same and the potential therapeutic effects and
safety of teplizumab and the Company's product candidates. 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 the Company'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 for teplizumab or other Company product candidates and
the potential for 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; the Company's dependence upon third parties;
substantial competition; the Company's need for additional
financing and the risks listed under "Risk Factors" in the
Company's annual report on Form 10-K for the year
ended December 31, 2020 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, whether as a result of new information,
future developments or otherwise, except as may be required by
applicable law. The information set forth herein speaks only as of
the date hereof.
Investor Contacts:
Robert Doody, VP of Investor
Relations
rdoody@proventionbio.com
484-639-7235
Sam Martin, Argot Partners
Sam@argotpartners.com
212-600-1902
Media Contact:
Lori Rosen, LDR Communications
lori@ldrcommunications.com
917-553-6808
Disclaimer: The content in this release is the sole
responsibility of the authors and does not necessarily represent
the official views or imply endorsement of the National Institutes
of Health.
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