OLDWICK, N.J., June 9, 2019 /PRNewswire/ -- Provention Bio, Inc.
(Nasdaq:PRVB), a clinical stage biopharmaceutical company dedicated
to intercepting and preventing immune-mediated disease, today
announced that results from the National Institutes of Health
(NIH)-sponsored "At-Risk" Study were published on-line in The New
England Journal of Medicine and presented at the Scientific
Sessions of the 79th Annual American Diabetes Association (ADA)
meeting. The "At-Risk" Study was sponsored by the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),
with additional support from JDRF. The study was conducted by the
Type 1 Diabetes TrialNet, an international collaboration aimed at
discovering ways to delay or prevent type 1 diabetes (T1D), and
evaluated Provention's PRV-031 (teplizumab) for the prevention or
delay of clinical T1D in relatives of type 1 diabetics at high-risk
of developing the disease. PRV-031 (teplizumab) is an
anti-CD3 monoclonal antibody in development for the interception
and prevention of clinical T1D.
The "At Risk" Study enrolled 76 participants ages 8 to 49 who
were "At-Risk" because they had two or more T1D autoantibodies and
abnormal glucose metabolism (dysglycemia); 72% of participants were
under the age of 18. Subjects were randomized to receive
either PRV-031 (teplizumab) or placebo.
Results from the study showed that a single 14-day course of
PRV-031 (teplizumab) significantly delayed the onset and diagnosis
of clinical T1D, as compared to placebo, by a median of 2 years in
children and adults considered to be at high risk. The median time
to clinical diagnosis of T1D for placebo participants was just over
24 months. In comparison, the median time for PRV-031
(teplizumab)-treated participants to clinical diagnosis of T1D was
just over 48 months (p=0.006). During the trial, 72% in the placebo
group developed clinical diabetes compared to only 43% of the
PRV-031 (teplizumab) group. PRV-031 (teplizumab) was well tolerated
and the safety data were consistent with prior studies in newly
diagnosed patients.
"This groundbreaking study demonstrates that we can use
immunotherapy, specifically PRV-031 (teplizumab), to prevent or
significantly delay the onset of clinical type 1 diabetes by at
least two years in individuals who will almost certainly progress
to clinical disease," said Dr. Eleanor
Ramos, Provention's Chief Medical Officer and Chief
Operating Officer. "More importantly, approximately 60% of
subjects in the study did not develop T1D following only one course
of PRV-031 therapy, double the placebo group. Teplizumab is the
first immune modulator to show a delay in the clinical onset of
type 1 diabetes."
Dr. Kevan Herold, M.D., Professor of Immunobiology and
Medicine at Yale University, lead author of the study, stated,
"These results have real clinical meaning for individuals at-risk
of developing clinical type 1 diabetes such as family members of
patients. Delaying the onset of clinical T1D may mean the disease
burden could be postponed to a point at which patients are better
able to manage their disease such as after infancy, elementary
school, high school or even college. With PRV-031 (teplizumab), we
may now be able to intervene and fundamentally change the
progression of T1D for these at-risk subjects. In addition, we look
forward to learning more as we observe patients during the study's
follow-up period, which will also evaluate the long-term outcomes
for those in whom the diagnosis of disease has been delayed to see
if they will be diagnosed with T1D or are protected."
"It's remarkable to see that a single course of two-week therapy
cut the incidence of diabetes by almost 50 percent during this
trial. These data clearly tell us short-term immunotherapy can
significantly slow down clinical onset of diabetes. Developing
immuno-modulatory drugs that don't require continuous treatment to
impact autoimmune disease is a major paradigm shift," said Jeffrey
Bluestone, PhD, A.W. and Mary Margaret Clausen Distinguished
Professor of Metabolism and Endocrinology at the UC San Francisco
(UCSF) Diabetes Center, President, CEO of the Parker Institute for
Cancer Immunotherapy, and a Director of Provention Bio.
"We especially want to congratulate TrialNet for conducting this
landmark study, and to thank the patients and families involved, as
well as the JDRF for their commitment to this study and the patient
community," stated Ashleigh Palmer,
CEO of Provention Bio. "We are delighted with the results,
which reinforce our confidence not only in PRV-031 (teplizumab),
but in Provention's strategic intent to intercept and prevent
immune-mediated disease. The ability to delay the onset of clinical
T1D is an enormous breakthrough, given that a recent study
indicated the life expectancy for patients diagnosed with T1D
before the age of ten is reduced by as much as 16 years on
average."
Mr. Palmer continued, "Based on these results, we are evaluating
a regulatory path forward for PRV-031 in at-risk individuals.
We are also assessing PRV-031 in newly-diagnosed T1D patients in
our Phase 3 PROTECT study, which commenced in April. Our broader
goal for PRV-031 is to address the continuum of T1D and provide
therapeutic options for this life-impacting and life-threatening
autoimmune disease that, until now, has seen no disease-modifying
innovation since the development of insulin a century
ago."
Conference Call and Webcast Information
Provention Bio will discuss these results via conference call
on Monday, June 10, 2019 at 8:30 AM ET. A webcast
presentation will also be available on the Investors page of the
Company's website, www.proventionbio.com. To access the
call, please dial 1-877-870-4263 (domestic) or 1-412-317-0790
(international) five minutes prior to the start time and ask to be
connected to the "Provention Bio Call". A webcast replay of the
call will be available beginning at 11:00 AM ET on the
day of the call.
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. 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. Provention is currently evaluating PRV-031 in patients with
recent onset T1D (the Phase 3 PROTECT Study); additional
information on the clinical trial is available at
clinicaltrials.gov. Provention is also evaluating
opportunities to advance development of teplizumab in relatives of
T1D patients at risk for developing the disease.
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), Crohn's disease, celiac disease, lupus, and certain
life-threatening viral diseases. Provention's diversified portfolio
includes advanced-stage product development candidates that have
undergone clinical testing by other companies. For more information
on Provention Bio, please visit www.proventionbio.com.
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 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:
Kimberly Minarovich or Sam Martin, Argot Partners
Kimberly@argotpartners.com or Sam@argotpartners.com
212-600-1902
Media:
David Rosen, Argot Partners
David.Rosen@argotpartners.com
856-630-0006
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SOURCE Provention Bio, Inc.