OLDWICK, N.J., April 9, 2019 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical
company dedicated to intercepting and preventing immune-mediated
diseases, today announced that it has dosed the first patient in
its Phase 3 PROTECT clinical trial of PRV-031 (teplizumab) in
patients with recent onset type 1 diabetes (T1D). PRV-031
(teplizumab) is an anti-CD3 monoclonal antibody in development for
the interception of TID.
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"PRV-031 (teplizumab) has the potential to be the first ever
disease modifying therapy in T1D, and the first drug class approved
for T1D since the introduction of insulin," said Dr. Kevan Herold, M.D., Professor of Immunobiology
and Medicine at Yale University. "Data
from prior clinical studies have indicated the potential of PRV-031
(teplizumab) to preserve functional beta cell mass, thereby
conserving natural insulin production and reducing the need for
insulin therapy. PRV-031 (teplizumab) may therefore offer a
much-needed improvement over currently approved treatment options
for T1D. I commend the patients, the Provention team, and my
fellow clinicians for undertaking this study and look forward to
further exploring its potential impact in newly-diagnosed T1D
patients."
The PROTECT study is designed to confirm the effect of PRV-031
(teplizumab) to slow the loss of insulin-producing beta cells and
preserve beta cell function, as measured by C-peptide, in children
and adolescents 8-17 years old who have been diagnosed with T1D in
the previous six weeks and with pre-specified beta cell reserve at
study entry.
"The initiation of the PROTECT study represents a significant
milestone in our efforts to develop agents that intercept or
prevent immune-mediated diseases," stated Ashleigh Palmer, CEO of Provention Bio. "If
successful, this pivotal Phase 3 trial could serve as the basis for
a Biologics License Application (BLA) for PRV-031 (teplizumab),
providing a therapeutic option that could transform the therapeutic
landscape for T1D."
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 80
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. Provention expects to
complete enrollment in the trial by the end of 2020.
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 of type 1 diabetes (T1D).
Provention Bio acquired PRV-031 from MacroGenics, Inc. in May
2018. 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. PRV-031 may also
hold potential in the prevention or delay in onset of T1D and is
currently being evaluated in the "At Risk" Study, a clinical trial
conducted by National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK) at TrialNet sites 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,
ulcerative colitis, 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
212-600-1902
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SOURCE Provention Bio, Inc.