RED BANK, N.J., Dec. 15, 2020 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today
announced the initiation of PROVENT (PROtocol for
coxsackievirus VaccinE in healthy voluNTeers),
a first-in-human study of its polyvalent inactivated coxsackievirus
B (CVB) vaccine candidate, PRV-101. Provention is developing
PRV-101 for the prevention of acute CVB infection and the potential
delay or prevention of type 1 diabetes (T1D) and celiac
disease.
CVB is a common enterovirus that frequently causes acute
morbidity such as respiratory disease, meningitis, pericarditis,
otitis, and hand-foot-mouth disease. CVB is also the leading cause
of viral myocarditis, a common condition that can cause fatal
arrythmia and lead to a serious chronic myocarditis that often
needs heart transplantation. CVB infection is significantly
associated with the development of T1D and celiac disease.
"The PRV-101 investigational vaccine is specifically designed to
prevent autoimmunity by primary prevention of a putative infectious
trigger," said Heikki Hyöty, co-founder of Vactech, MD, Ph.D.,
Professor of Virology at Tampere
University, Finland. "A
substantial body of evidence points to the role of CVB as a trigger
in the initiation of two common autoimmune diseases, T1D and celiac
disease. Based on these data, PRV-101 represents an exciting
vaccine candidate to intercept the development of these autoimmune
disorders. In addition, it has the potential to target several
acute CVB diseases and myocarditis."
PROVENT is a placebo-controlled, double-blind, randomized
first-in-human study being conducted at the Clinical Research
Services Turku - CRST Oy, a clinical trial unit in Turku, Finland. The study's primary endpoint
is the safety of two dose levels of PRV-101 in healthy adult
volunteers provided three administrations with 4-week intervals.
Tolerability and immunogenicity will also be evaluated. Results of
PROVENT are expected in the second half of 2021.
"Initiation of this first-in-human clinical trial is a
significant milestone in full alignment with Provention's
foundational vision to seek out autoimmunity early to intercept and
prevent debilitating and life-threatening diseases," said
Francisco Leon, MD, Ph.D., chief
scientific officer, and co-founder, Provention Bio. "We look
forward to continuing to advance the development of PRV-101 to
determine whether a common autoimmune disease can be delayed or
prevented with a vaccine against an infectious trigger. If
successful, PRV-101 has the potential to be the first vaccine
to prevent CVB and could potentially decrease the incidence of T1D
and celiac disease."
About Coxsackievirus B (CVB) Infection
and Immunity:
CVB is a common, potentially serious infection that damages
insulin-producing cells and gut-lining cells, triggering a T-cell
immune response that is believed to cause autoimmunity in
predisposed individuals. The only persistent infection
significantly associated with the development of type 1 diabetes
(T1D) and celiac autoimmunity, CVB has been found in the pancreas
of ~60% of patients with T1D and the gut of ~20% of patients with
celiac disease.
About PRV-101:
PRV-101 is an investigational polyvalent vaccine being
developed for the prevention of acute coxsackievirus B
(CVB) infection and the potential delay or prevention of type
1 diabetes (T1D) and celiac disease. It is specifically designed to
prevent autoimmunity by the primary prevention of a putative
infectious trigger. PRV-101 has the potential to be the first
vaccine to prevent CVB as well as up to ~50% of T1D and ~20% of
celiac disease. Patents covering the use of PRV-101 in these
indications have been licensed in from Vactech Ltd.
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 disease. The Company has submitted
a BLA to the FDA for its lead investigational drug candidate,
teplizumab, for the delay or prevention of clinical type 1 diabetes
(T1D) in at-risk individuals. 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 FD. 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.
About Vactech Ltd.:
Vactech develops and licenses vaccines and novel technologies
for vaccines and diagnostics with a pipeline of early stage product
candidates focused on Type 1 Diabetes, Celiac Disease, Asthma &
Allergy and diagnostics. Vactech is a privately owned company
having a track record of collaboration with both industrial and
academic partners. Vactech has engaged in strategic partnership
with Provention Bio, Inc. especially in the field of PRV-101.
Please see the company's website at www.vactech.fi for
additional information.
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-101. 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 Contact:
Lori Rosen, LDR Communications
lori@ldrcommunications.com
917-553-6808
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SOURCE Provention Bio, Inc.