OLDWICK, N.J., Aug. 8, 2019 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical company
dedicated to intercepting and preventing immune-mediated disease,
today announced that it has dosed the first patients in its PREVAIL
(PRV-3279 EVAluation In Lupus) study, a Phase 1b/2a clinical trial evaluating
PRV-3279. PRV-3279 is a humanized diabody (a bispecific
scaffold biologic 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.
The PREVAIL study consists of two parts: a Phase 1b trial in healthy volunteers, followed by a
Phase 2a trial in SLE patients. The randomized, double-blind,
placebo-controlled, multiple ascending dose Phase 1a study will
evaluate the safety, tolerability, pharmacokinetics,
pharmacodynamics and immunogenicity of PRV-3279 in 16 healthy
volunteers. Upon successful completion of the Phase 1a study,
Provention plans to initiate the Phase 2a portion of the study in
lupus patients.
"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, 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 inhibition
of activated B cells, while sparing non-activated B cells from
depletion or inactivation, thereby offering the potential for a
more effective yet safer alternative to current B-cell targeted
therapies. We look forward to reporting data from Part 1 of
the study in the first half of 2020."
Results from a prior single ascending dose Phase 1 study
established proof of mechanism and showed that PRV-3279 was
well-tolerated. In addition, a single dose of PRV-3279
demonstrated an inhibitory effect on the immunogenicity of
hepatitis A vaccine provided to volunteers during the
trial.
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 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 Provention Bio, Inc.
Provention Bio, Inc. (Nasdaq: PRVB) is a clinical-stage
biopharmaceutical company leveraging a transformational drug
development strategy that is focused on the prevention or
interception of immune-mediated disease. Provention's mission
is to in-license, transform and develop therapeutic candidates
targeting the high morbidity, mortality and escalating costs of
autoimmune and inflammatory diseases including: type 1 diabetes
(T1D), Crohn's disease, celiac disease, and lupus. Provention's
diversified portfolio includes advanced-stage product development
candidates that have undergone clinical testing by other
companies.
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.