OLDWICK, N.J., March 12, 2020 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a clinical-stage biopharmaceutical company
dedicated to intercepting and preventing immune-mediated diseases,
today announced positive top-line results from the Phase
1b portion of the PREVAIL (PRV-3279
EVAluation In Lupus) study evaluating PRV-3279 in healthy
volunteers. PRV-3279 is a humanized diabody 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 and prevent or reduce
the immunogenicity of biotherapeutics, including gene therapy
products.
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The Phase 1b portion of the
PREVAIL study was a double-blind, placebo-controlled, multiple
ascending dose study in 16 healthy volunteers. PRV-3279 was
well-tolerated, with no serious adverse events. Pharmacokinetic
parameters were generally dose-proportional, and high levels of B
cell engagement resulted in durable pharmacodynamic responses. As
expected, PRV-3279 did not deplete B cells and demonstrated
dose-proportional, extensive and sustained binding to circulating B
lymphocytes, as well as an extended pharmacodynamic effect as
demonstrated by the reduction in circulating immunoglobulin M
levels. While anti-drug antibody production was observed at both
dose levels tested, immunogenicity was found not to affect
exposure, safety or pharmacodynamic parameters.
"These results build on prior clinical data with PRV-3279 and
existing evidence of the role of CD32B in lupus. These data further
increase our enthusiasm for this potentially groundbreaking
treatment of B-cell driven immunologic conditions with high unmet
need, such as lupus," stated Francisco
Leon, M.D., Ph.D., Co-founder and Chief Scientific Officer
of Provention Bio. "We believe that PRV-3279 is uniquely
differentiated to allow for rapid and durable inhibition of
activated B cells without depletion, similar to the effects of our
other drug, teplizumab, on T cells. PRV-3279 may therefore,
ultimately strike an optimal balance between safety and efficacy in
lupus and other B cell-mediated autoimmune disorders. In
addition, PRV-3279 has a unique potential to serve as the backbone
in the prevention of immunogenicity associated with gene therapy
and other biotherapeutics. The data reported today provides a
strong rationale to pursue this dual development path."
Based on the results, Provention plans to commence the Phase 2a
portion of the PREVAIL study in lupus patients in the first half of
2021. These Phase 1b results will
also enable a second development pathway for the prevention of
immunogenicity of biotherapeutics such as gene therapy
products.
"These results advance our mission focused on intercepting or
preventing a broad range of immune-mediated diseases," said
Ashleigh Palmer, CEO and Co-founder,
Provention Bio. "Similar to teplizumab, our lead candidate for the
prevention or delay of type 1 diabetes, PRV-3279 has the potential
to intercept the disease process and transform the treatment
landscape for its targeted indications. In addition to advancing to
the proof-of-concept, Phase 2 portion of the PREVAIL study in lupus
patients, we are exploring collaboration opportunities to support
the development of PRV-3279 to prevent or reduce the immunogenicity
associated with biotherapeutics such as gene therapy."
About PRV-3279
PRV-3279 is a humanized diabody (a bispecific scaffold biologic
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 has the potential to address a wide variety of other
autoimmune conditions where B cells play a role, from large
indications such as rheumatoid arthritis and multiple sclerosis, to
orphan diseases such as idiopathic thrombocytopenic purpura,
neuromyelitis optica, pemphigus or myasthenia gravis.
Provention has prioritized lupus as our lead autoimmune indication
for its unmet need and since proof-of-mechanism for CD32B agonism
has been established in this disease. 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 (PRV-3279 EVAluation In Lupus) study; additional
information on the clinical trial is available
at www.clinicaltrials.gov (Number NCT03955666).
About Systemic Lupus Erythematosus (SLE)
Systemic lupus erythematosus (SLE), also known as
lupus, is a chronic autoimmune disorder that can affect nearly
every major organ system, causing inflammation, tissue injury,
organ damage, and in some patients, organ failure. At least
1.5 million Americans are afflicted by lupus. The pathogenesis of
lupus is characterized by an abnormal overactivation of B cells and
subsequent pathologic production of autoantibodies. Mutations in
the CD32B gene in humans are associated with an increased
likelihood of lupus, and reduced expression of CD32B is apparent in
B cells from lupus patients.
About Provention Bio, Inc.
Provention Bio, Inc. (Nasdaq: PRVB) is a clinical-stage
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 PRV-031 (teplizumab), a
pre-commercial-stage candidate that has been shown to delay the
onset of end-stage type one diabetes (T1D) in at-risk individuals
with pre-symptomatic disease. Teplizumab has been granted
Breakthrough Therapy designation from the U.S. Food and Drug
Administration. The company's portfolio includes additional
clinical-stage product development candidates that have
demonstrated 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
within the meaning of the Private Securities Litigation Reform Act
of 1995. 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
failure to obtain FDA approvals or clearances and noncompliance
with FDA regulations; uncertainties of patent protection and
litigation; limited research and development efforts and 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,
2018 and any subsequent filings with the Securities and
Exchange Commission (SEC). 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.
Investors:
Sam Martin, Argot Partners
Sam@argotpartners.com
212-600-1902
Media:
David Rosen, Argot Partners
David.Rosen@argotpartners.com
212-600-1902
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SOURCE Provention Bio, Inc.