Principia Announces First Patient Enrolled in Sanofi’s Phase 3 Trial of SAR442168 in Relapsing Multiple Sclerosis
23 Junho 2020 - 2:15AM
Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage
biopharmaceutical company focused on developing treatments for
immune-mediated diseases, today announced that the first patient
has been enrolled in its partner Sanofi’s Phase 3 clinical trial of
SAR442168 in patients with relapsing multiple sclerosis (RMS). Upon
dosing, Principia will be entitled to a $50 million milestone
payment. SAR442168, discovered by Principia and formerly known as
PRN2246, is a Bruton’s tyrosine kinase (BTK) inhibitor that crosses
the human blood-brain barrier and modulates immune cell function in
both the periphery and in the central nervous system (CNS), which
shows promise for the potential treatment of CNS diseases.
“We are delighted that Sanofi has initiated a Phase
3 trial in patients with relapsing MS,” said Roy Hardiman, chief
business officer at Principia. “Our partnership with Sanofi, a
company with a long track record of bringing novel therapies to the
multiple sclerosis community, is highly collaborative. We continue
to evaluate our Phase 3 co-funding option that could increase
Principia’s economic rights.”
About this Phase 3 Trial of
SAR442168As part of a broad Phase 3 clinical program in
MS, Sanofi has initiated a global, randomized, double-blind
efficacy and safety trial comparing SAR442168 to teriflunomide
(Aubagio®) in 900 participants with relapsing forms of MS. The
trial will assess efficacy of daily SAR442168 compared to a daily
dose of 14 mg teriflunomide measured by annualized adjudicated
relapse rate (ARR) in participants with relapsing forms of MS.
Secondary objectives will assess efficacy of SAR442168 compared to
teriflunomide on disability progression, MRI lesions, cognitive
performance and quality of life.
About
SAR442168SAR442168 is being developed to
potentially treat MS and other CNS diseases, in part by penetrating
the blood-brain barrier and modulating B cells and other immune
cells in the CNS. During neuro-inflammation, the number of B cells
in the brain increases, which is thought to play a central role in
the pathology of MS and other CNS diseases. This provides the
potential of targeting the adaptive and innate immunity in both the
periphery and within the CNS. In late 2017, Principia formed a
collaboration with Sanofi under which Principia granted Sanofi an
exclusive, worldwide license to develop and commercialize
SAR442168.
About Principia BiopharmaPrincipia
is a late-stage biopharmaceutical company dedicated to bringing
transformative therapies to patients with significant unmet medical
needs in immune-mediated diseases. Through Principia’s proprietary
Tailored Covalency® platform, our strategy is to build and advance
a pipeline of best-in-class drug candidates with significant
therapeutic benefits, limit unintended side effects, improve
quality of life and over time modify the course of disease. This
highly reproducible approach enables the company to pursue multiple
programs efficiently, having discovered three drug candidates.
Rilzabrutinib, a reversible covalent BTK inhibitor, is being
evaluated in a global Phase 3 clinical trial in participants with
pemphigus, a Phase 1/2 clinical trial in participants with immune
thrombocytopenia (ITP), and the company plans to initiate a Phase 2
clinical trial in participants with IgG4-Related Diseases and a
Phase 3 trial in ITP. PRN2246/SAR442168 is a covalent BTK inhibitor
which crosses the blood-brain barrier and is partnered with
Sanofi. Sanofi has announced that SAR442168 will be evaluated
in four Phase 3 clinical trials in participants with relapsing and
progressive forms of multiple sclerosis. PRN473 Topical, a topical
reversible covalent BTK inhibitor designed for immune-mediated
diseases that could benefit from localized application to the skin,
is being evaluated in a Phase 1 trial. For more information,
please visit www.principiabio.com.
Forward-Looking StatementsThis
press release contains forward-looking statements. These
forward-looking statements reflect the current beliefs and
expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, the initiation, timing, scope
and success of Sanofi’s Phase 3 clinical trial program, Principia’s
expectations regarding the Principia pipeline of product
candidates, the potential patient benefits of Principia’s pipeline,
including of rilzabrutinib to rapidly and effectively treat
pemphigus while significantly reducing the exposure to moderate to
high CS doses, the safety and efficacy of rilzabrutinib, the
planned patient enrollment for the Phase 3 PEGASUS trial, the
initiation and timing of Principia’s Phase 2 clinical trial in
participants with IgG4-Related Diseases and Phase 3 clinical trial
in ITP, and the initiation, timing, scope and success of additional
clinical trials and results. Such forward-looking statements
involve known and unknown risks, uncertainties, and other important
factors that may cause Principia’s actual results,
performance, or achievements to be materially different from those
expressed or implied by the forward-looking statements. For a
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to the Principia’s
business in general, see the risk factors set forth in
Principia’s reports filed with the Securities and Exchange
Commission. Any forward-looking statements contained in this press
release speak only as of the date hereof, and Principia
specifically disclaims any obligation to update any forward-looking
statement, whether as a result of new information, future events or
otherwise.
Investor Contact
Christopher Chai, CFO
ir@principiabio.com
Media Contact
Paul Laland, VP of Corporate Communications
paul.laland@principiabio.com
415.519.6610
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