RED BANK, N.J., Oct. 26, 2021 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today
announced positive interim results from PROVENT (PROtocol
for coxsackievirus VaccinE in healthy
voluNTeers), a first-in-human study of PRV-101, a polyvalent
inactivated coxsackievirus B (CVB) vaccine candidate targeting all
five key CVB strains associated with type 1 diabetes (T1D)
autoimmunity. Provention is developing PRV-101 for the prevention
of acute CVB infection and the potential delay or prevention of T1D
and celiac disease.
In this interim analysis, PRV-101 met the primary endpoint
demonstrating that it was well tolerated in this study, with no
treatment-emergent Serious Adverse Events, Adverse Events of
Special Interest, or Adverse Events that led to study drug
discontinuation or study withdrawal. PRV-101 also met the secondary
efficacy endpoint as it induced high titers of viral-neutralizing
antibodies against all CVB serotypes included in the vaccine in a
dose- dependent fashion.
PRV-101, licensed from Vactech Oy (Tampere, Finland), is designed to prevent
acute CVB infections and, in individuals at increased risk due to
genetic susceptibility, to prevent CVB-triggered autoimmune damage
to pancreatic beta cells that often progresses to T1D and damage to
intestinal cells that may lead to celiac disease.
PROVENT is a Phase 1 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 were also
evaluated. The interim analysis was conducted after all trial
participants completed 4 weeks of follow-up after the
3rd dose (Week 12) to assess vaccine response and
safety. An additional 6-month safety follow up will be conducted
and final trial results are expected in the first half of 2022.
"These interim results from this first-in-human trial are
incredibly exciting," said Francisco
Leon, MD, PhD, chief scientific officer and co-founder of
Provention Bio. "We thank our collaborators for their pioneering
efforts, enabling PRV-101 to take a significant stride forward to
producing clinical data to demonstrate its potential to be the
first vaccine to prevent CVB and ultimately decreasing the global
incidence of T1D and celiac disease. We look forward to the
final results of this trial next year and continuing the
advancement of PRV-101."
"This is a very important milestone creating a solid basis for
the continuation of the development program. We are delighted to
see that the PRV-101 vaccine induced high neutralizing antibody
titers against CVBs since these antibodies mediate protection
against CVBs," said Heikki Hyoty, PhD, professor of virology,
Tampere University, Finland, and scientific co-founder of Vactech
Oy.
"The causal link between CVB infection in childhood and the
onset of T1D is compelling", said Jeffrey
Almond, PhD, visiting professor of microbiology,
University of Oxford and former global
head of research at Sanofi Pasteur. "Provention Bio has taken
the lead by producing a CVB vaccine that is already showing very
good results in a Phase 1 study. I look forward to seeing the
rapid further development of this vaccine and its use to reduce the
burden of T1D in children."
The Company has posted an update to its corporate slide
presentation containing additional details pertaining to the
information commented on within this press release. The
presentation can be found at www.proventionbio.com in the
Investor's section.
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. A 50% reduction in T1D autoimmunity was observed in
the offspring of mothers with CVB immunity during pregnancy.
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.
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's pipeline
includes clinical-stage product candidates that have demonstrated
in pre-clinical or clinical studies proof-of-mechanism and/or
proof-of-concept in autoimmune diseases, including type 1 diabetes,
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 the potential
of PRV-101 for the prevention of acute CVB infection and the
potential delay or prevention of type 1 diabetes (T1D) and celiac
disease and future development plans. These statements may be
identified by the use of forward-looking words such as "will,"
"believe," and "may," 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, interim data referenced in
this release could change as these data are finalized; 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 quarterly report on Form 10-Q for the quarter
ended June 30, 2021 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
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SOURCE Provention Bio, Inc.