PRV-101 continued to be well tolerated and elicited durable
high titers of virus-neutralizing antibodies in a dose-dependent
fashion in healthy volunteers
RED
BANK, N.J., March 28,
2022 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq:
PRVB), a biopharmaceutical company dedicated to intercepting and
preventing immune-mediated disease, today announced positive
results from the final analysis of its first-in-human PROVENT study
of PRV-101, a polyvalent inactivated coxsackievirus B (CVB) vaccine
candidate targeting all key CVB strains associated with type 1
diabetes (T1D) autoimmunity. Provention is developing PRV-101 for
the prevention of acute CVB infection and its complications, as
well as for the potential delay or prevention of associated
autoimmune disorders T1D and celiac disease.
In this final analysis, 6 months following the last dose of the
vaccine, PRV-101 met the primary endpoint confirming the
tolerability observed in the previously reported interim analysis,
with no Treatment-Emergent Serious Adverse Events, Adverse Events
of special interest, or Adverse Events leading to study drug
discontinuation or study withdrawal.
The results also showed durability of viral neutralizing
antibody (VNT) responses. At this 6-month post-final dosing time
point, the percentages of subjects in the high-dose PRV-101 arm who
maintained high titers of VNT were 100% for the majority of
serotypes included in the vaccine and no less than 90% for all.
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 conducted at the Clinical Research
Services Turku - CRST Oy, a clinical trial unit in Turku, Finland. The study's primary endpoint
was 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.
"These final results from this first-in-human trial of PRV-101
are extremely encouraging," said Francisco
Leon, M.D., Ph.D., chief scientific officer and co-founder
of Provention Bio. "We appreciate all of our collaborators and
partners on this program who enabled 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
decrease the global incidence of T1D and celiac disease. We look
forward to potentially partnering to advance this program in the
future."
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, its potential to be the first vaccine to prevent CVB and
ultimately decrease the global incidence of T1D and celiac disease,
and potentially partnering to advance this program in the future.
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, risks related to
clinical research and development including that results of future
clinical trials may not be consistent with prior results, be
positive or may not support regulatory approval or
commercialization, 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 annual report on Form 10-K for the
period ended December 31, 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 Contact:
Robert Doody, VP of Investor
Relations
rdoody@proventionbio.com
484-639-7235
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SOURCE Provention Bio, Inc.