OLDWICK, N.J., Aug. 31, 2020 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today
announced the initiation of the Phase 2b PROACTIVE
(PROvention Amgen Celiac
ProtecTIVE) study of PRV-015, an anti-interleukin-15
monoclonal antibody, in adult celiac patients not responding to a
gluten-free diet, a condition known as 'Non-Responsive Celiac
Disease' (NRCD). Provention is developing PRV-015 under its 2018
collaboration with Amgen.
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"Celiac disease remains the most prevalent autoimmune disease
with no therapeutic treatment, and gluten-free diets are unable to
effectively manage the disease in a large subset of patients, given
the widespread use of gluten in foods, medications and consumer
products, as well as the contamination of apparently 'gluten-free'
products," said Peter H.R. Green,
MD, Phyllis & Ivan Seidenberg Professor of Medicine; Director,
Celiac Disease Center at Columbia
University. "The long-term effects of the activation of the
immune system by gluten in non-responsive celiac disease can be
devastating, including the potential development of intestinal
lymphoma. Based on prior data, PRV-015 represents an exciting
therapeutic candidate to potentially intercept the damaging effects
of contaminating gluten."
"PRV-015 has the potential to be the first-ever approved
therapeutic for celiac disease," stated Francisco Leon, MD, PhD, Chief Scientific
Officer and Co-Founder, Provention Bio. "We believe that PRV-015 is
the only investigational candidate that has been shown in clinical
studies to simultaneously reduce gluten-induced symptoms and
markers of intestinal inflammation as compared to placebo. We look
forward to expanding our clinical experience with this candidate,
consistent with our mission to bring forward therapies designed to
intercept or prevent immune-mediated diseases."
The placebo-controlled, double-blind, randomized study initiated
will examine the efficacy and safety of three dose levels of
PRV-015 versus placebo, administered every two weeks for six
months. The study does not require a gluten challenge and patients
are asked to maintain their usual diet. The trial is expected to
enroll approximately 220 adults with NRCD across approximately 40
sites in the United States,
Canada and Europe. The primary endpoint of the study is
the efficacy of PRV-015 as measured by the CeD-PRO (Celiac Disease
Patient-Reported Outcome).
PRV-015 has been studied in six completed clinical trials to
date. In a prior randomized double-blind, placebo-controlled Phase
2a study in 63 adults with celiac disease, PRV-015 reduced
intestinal inflammation and symptoms associated with celiac disease
after a controlled gluten challenge as compared to placebo.
Specifically, at 12 weeks, a decrease of 38% (p=0.02) % in the
CeD-PRO symptom measure and a decrease of 38% (p=0.03) in
intestinal intraepithelial lymphocytes was observed.
About the Co-Development Collaboration with Amgen:
In November 2018, Amgen and
Provention Bio announced a licensing and co-development agreement
for PRV-015 (also known as AMG 714). Under the terms of the
agreement, Provention will conduct and fund the Phase 2b trial in non-responsive celiac disease (NRCD).
Amgen will be responsible for the manufacturing of PRV-015. Upon
completion of the Phase 2b trial,
Provention will be eligible to receive a $150 million milestone payment, as well as
additional regulatory milestone payments and royalties if Amgen
continues the development of this product candidate.
About PRV-015:
PRV-015 (also known as AMG 714) is a novel, fully human
anti-IL-15 monoclonal antibody which Provention is developing for
the treatment of gluten-free diet non-responsive celiac disease
(NRCD). The pro-inflammatory cytokine interleukin 15 (IL-15) has
been identified as a major mediator in the pathophysiology of
celiac disease. PRV-015 binds to and inhibits IL-15 and has emerged
as a leading investigational candidate for the treatment of
non-responsive celiac disease, in which patients continue to have
disease activity despite an ongoing gluten-free diet. In a Phase 2a
clinical trial with 63 celiac patients, data showed a reduction in
inflammation and symptoms as compared to placebo after a controlled
gluten challenge. Provention is currently evaluating PRV-015 in the
Phase 2b PROACTIVE
(PROvention Amgen Celiac ProtecTIVE) Study. PRV-015 is
being developed under Provention's 2018 licensing and
co-development agreement with Amgen. More information on the study
is available at https://proactiveceliac.com/.
About Non-responsive Celiac Disease:
Celiac disease is a systemic autoimmune disease triggered by
gluten consumption in genetically susceptible individuals.
Approximately 1% of the western population is affected by celiac
disease. The pathophysiology of celiac disease is characterized by
an abnormal immune response to gluten, the main protein present in
some of the most common cereals (wheat, barley, rye). Modern diets
are increasingly enriched with gluten and it is also used as an
additive in processed foods, cosmetics and oral medications. Gluten
is also present in trace amounts in foods labeled as "gluten-free",
as a tableting excipient, and in certain consumer products. As a
result of the difficulty in maintaining total avoidance of gluten
while on a gluten-free diet (GFD), gluten contamination causes 50%
or more of all diagnosed celiac patients on a GFD to continue to
experience disease activity. Patients who continue to have symptoms
despite attempting to maintain a GFD are deemed to have NRCD.
Approximately 1.5 million patients in the U.S. have NRCD.
Celiac disease causes debilitating symptoms and serious medical
complications, including intestinal mucosal damage which could lead
to intestinal lymphoma. There are no approved medications for
celiac disease.
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 clinical-stage candidate that has
been shown in a clinical study to delay the onset of
insulin-dependent type 1 diabetes (T1D) in at-risk patients during
the presymptomatic phase of the disease as compared to placebo. The
Company's portfolio includes additional clinical product
development 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.
Forward Looking Statements:
Certain statements in this press release are forward-looking,
including but not limited to, statements relating to the Company's
studies, the potential health benefits of and planned research and
development efforts for PRV-015. 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 delays in, or failure to obtain FDA approvals or
clearances and 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; 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, our quarterly reports on form
10-Q, 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. The information set forth herein speaks only as of the
date hereof.
Investor Contact:
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.