RED BANK, N.J., Jan. 20, 2022 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today
announced the initiation of the Phase 2a PREVAIL-2 study
(PRV-3279 EVAluation In Lupus- Phase 2). PRV-3279 is an
investigational humanized bispecific DART molecule targeting the
B-cell surface proteins CD32B and CD79B, which has the potential to
intercept the pathophysiology of systemic lupus erythematosus (SLE)
and other B cell-mediated autoimmune diseases, as well as to
prevent the immunogenicity of biotherapeutic products such as gene
therapy.
The PREVAIL-2 study is a Phase 2a proof-of-concept (POC) study
in moderate-to-severe SLE patients induced into response with a
short course of corticosteroids, and then monitored for relapse,
after randomization to either PRV-3279 or placebo treatment. This
design enables the withdrawal of most concomitant medications and
clear POC evaluation. The study will be conducted in the US and
Hong Kong. Screening has commenced
in the US with the goal of identifying and enrolling approximately
100 patients to 6 monthly infusions of PRV-3279 or placebo, with
primary efficacy readout at 24 weeks. PRV-3279 was well-tolerated
in a prior single ascending dose Phase 1 study and a multiple
ascending dose Phase 1b study,
PREVAIL-1, establishing proof of mechanism with long-lasting
inhibition of B cell function as shown by reduction in IgM
production 8 weeks post last dose of PRV-3279. These results,
together with observations that CD32B genetic variants are
associated with SLE, and that PRV-3279 inhibits B cells isolated
from SLE patients, support evaluation in SLE.
"PRV-3279 offers an elegant mechanism of action designed to
intercept and ameliorate the overactive B cell-driven pathology of
lupus and other autoimmune diseases," stated Francisco Leon, MD PhD, Co-founder and Chief
Scientific Officer of Provention Bio. "We believe that PRV-3279
allows for rapid inhibition of activated B cells, while sparing
non-activated B cells from depletion or inactivation, which may
offer the potential for an alternative to current B cell-targeting
therapies with a more favorable safety profile. We look forward to
reporting data from PREVAIL-2 in the first half of 2024."
"PRV-3279 brings together two relevant immune protein targets to
strategically modify their interactions. CD79B is part of the B
cell receptor and CD32B is a natural regulator of B cells," said
Joan Merrill, MD, Director of
Clinical Projects, Arthritis and Clinical Immunology Program at
Oklahoma Medical Research Foundation, who has led international
efforts to develop more interpretable trials. "Stratification and
pre-defined subset analysis in PREVAIL-2 of a potentially highly
responsive SLE population using a B cell gene signature may
identify patients most likely to benefit from PRV-3279 therapy in
the future."
About Systemic Lupus Erythematosus (SLE)
Systemic lupus erythematosus (SLE) is a chronic autoimmune
disease that can cause inflammation and pain throughout the body. A
person with SLE might experience joint pain, skin sensitivities,
and rashes, and issues with internal organs (brain, lungs, kidneys,
and heart). The exact cause of SLE isn't known, but several factors
are associated with the disease, including genetics, environment,
sex, and hormones. The current goal of treatment for SLE is to ease
symptoms and minimize organ damage. No cure for SLE exists.
About PRV-3279
PRV-3279 is an investigational humanized bispecific DART
molecule targeting the B-cell surface proteins, CD32B and
CD79B. Simultaneous engagement of the CD32B and CD79B
receptors triggers inhibition of B cell function and suppression of
autoantibody production, thereby regulating B cells without causing
depletion. Provention is initially developing PRV-3279 for the
interception of systemic lupus erythematosus (SLE), a chronic
autoimmune disorder characterized by an abnormal overactivation of
B cells and subsequent pathologic production of
auto-antibodies. PRV-3279 also has the potential to prevent or
reduce the immunogenicity of biotherapeutics, including but not
limited to gene therapy vectors and transgenes. Provention is
currently evaluating PRV-3279 in the PREVAIL-2 (PRV-3279 EVAluation
In Lupus) study; additional information on the clinical trial is
available at www.clinicaltrials.gov (Number NCT05087628).
The placebo-controlled, double-blind, randomized study initiated
will examine the efficacy and safety of PRV-3279 versus placebo,
administered every four weeks for five months, followed by an
eight-week efficacy and safety follow up. The primary endpoint
of the study is to evaluate the ability of PRV-3279 to reduce SLE
flare. The trial is expected to enroll approximately 100 adults
with SLE across approximately 28 sites in the United States and Hong Kong. The Company
and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a
wholly-owned subsidiary of Huadong Medicine Co., Ltd., have a
strategic collaboration to develop and commercialize PRV-3279 in
Greater China (mainland
China, Hong Kong, Macau and Taiwan.)
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 timing of
data from the PREVAIL-2 study and the potential for PRV-3279 to
prevent or reduce the immunogenicity of biotherapeutics, its
potential rapid inhibition of activated B cells, while sparing
non-activated B cells from depletion or inactivation, and its
potential to be an alternative to current B cell-targeting
therapies with a more favorable safety profile. 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 delays in
identifying and enrolling patients for the PREVAIL-2 study; delays
in or failure to obtain FDA approvals for PRV-3279 or other Company
product candidates;; 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 September 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
Media Contact:
Lori Rosen, LDR
Communications
lori@ldrcommunications.com
917-553-6808
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SOURCE Provention Bio, Inc.