Vigil Neuroscience Provides Update on Clinical Development Strategy to Pursue Potential Accelerated Approval Pathway for Iluzanebart in ALSP
18 Julho 2024 - 8:00AM
Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage
biotechnology company committed to harnessing the power of
microglia for the treatment of neurodegenerative diseases,
announced today an update following a Type C Meeting with the U.S.
Food and Drug Administration (FDA) to its clinical development
strategy for its IGNITE clinical trial evaluating iluzanebart in
people with adult-onset leukoencephalopathy with axonal spheroids
and pigmented glia (ALSP).
“We are updating our clinical development
strategy to preserve the IGNITE dataset for a final analysis at 12
months, which we believe provides the best opportunity to leverage
our biomarker strategy and to pursue the potential accelerated
approval pathway. As part of this strategy, we will not conduct an
interim analysis prior to the study completion,” said Ivana
Magovčević-Liebisch, Ph.D., J.D., President and Chief Executive
Officer of Vigil. “This follows a Type C meeting with the FDA where
the Agency stated that it was open to considering the accelerated
approval pathway and that we should provide additional data to
support our proposed development plan. We look forward to
continuing to engage with the FDA as we work to bring this
potential therapy to patients in need as quickly as possible.”
The Company plans to report the final analysis
from the IGNITE clinical trial, including all patients at 12 months
dosed with either 20 mg/kg or 40 mg/kg of iluzanebart in the first
half of 2025.
About IGNITE Clinical
Trial
IGNITE is a global Phase 2 clinical trial to
evaluate iluzanebart as a treatment for symptomatic ALSP patients
who have a confirmed CSF1R gene mutation. Patients enrolled in the
trial receive an intravenous (IV) infusion of iluzanebart at 20
mg/kg or 40 mg/kg approximately every four weeks for a treatment
duration of one year. The trial is evaluating safety, biomarker
endpoints, including magnetic resonance imaging (MRI) and
neurofilament light chain (NfL), and clinical endpoints using
standard cognitive, motor and functional assessments.
About Iluzanebart
Iluzanebart, Vigil’s lead clinical candidate, is
a fully human monoclonal antibody targeting human triggering
receptor expressed on myeloid cells 2 (TREM2), which is responsible
for maintaining microglial cell function. TREM2 deficiency is
believed to be a driver of certain neurodegenerative diseases.
Iluzanebart is in development for rare microgliopathies, such as
ALSP, as well as other neurodegenerative diseases for which TREM2
and/or microglia deficiency is believed to be a key driver of
disease pathway.
About Vigil
Neuroscience Vigil Neuroscience is a clinical-stage
biotechnology company focused on developing treatments for both
rare and common neurodegenerative diseases by restoring the
vigilance of microglia, the sentinel immune cells of the brain.
Vigil is utilizing the tools of modern neuroscience drug
development across multiple therapeutic modalities in its efforts
to develop precision-based therapies to improve the lives of
patients and their families. Iluzanebart, Vigil’s lead clinical
candidate, is a fully human monoclonal antibody agonist targeting
human triggering receptor expressed on myeloid cells 2 (TREM2) in
people with adult-onset leukoencephalopathy with axonal spheroids
and pigmented glia (ALSP), a rare and fatal neurodegenerative
disease. Vigil is also developing VG-3927, a novel small molecule
TREM2 agonist, to treat common neurodegenerative diseases
associated with microglial dysfunction, with an initial focus on
Alzheimer’s disease (AD) patients, including some who carry TREM2
and other disease-associated variants.
Forward-Looking Statements
This press release includes certain disclosures
that contain “forward-looking statements” of Vigil Neuroscience
(“Vigil” or the “Company”) that are made pursuant to the safe
harbor provisions of the federal securities laws, including,
without limitation, express or implied statements regarding: the
potential therapeutic benefit of iluzanebart, beliefs about
observations made analyzing preclinical study and clinical trial
data to date; our ability to advance the clinical development of
iluzanebart; the progress and timing of the clinical development of
Vigil’s programs, including the availability of, and expected
timing for reporting, final data from the IGNITE Phase 2 clinical
trial; and the success and timing of the Company’s interactions
with regulatory authorities, including with the FDA regarding the
accelerated approval pathway. Forward-looking statements are based
on Vigil’s current expectations and are subject to inherent
uncertainties, risks and assumptions that are difficult to predict.
Factors that could cause actual results to differ include, but are
not limited to, risks and uncertainties related to uncertainties
inherent in the development of product candidates, including the
conduct of research activities and the conduct of clinical trials;
whether results from preclinical studies and clinical trials will
be predictive of the results of later preclinical studies and
clinical trials; the timing and content of additional regulatory
information from the FDA; as well as the risks and uncertainties
identified in the Company’s filings with the Securities and
Exchange Commission (SEC), including Vigil’s Quarterly Report on
Form 10-Q for the quarter ended March 31, 2024 and in any
subsequent filings Vigil makes with the SEC. Forward-looking
statements contained in this announcement are made as of this date,
and Vigil undertakes no duty to update such information except as
required under applicable law. Readers should not rely upon the
information on this page as current or accurate after its
publication date.
Internet Posting of
Information
Vigil Neuroscience routinely posts information
that may be important to investors in the 'Investors' section of
its website at https://www.vigilneuro.com. The company encourages
investors and potential investors to consult our website regularly
for important information about Vigil Neuroscience.
Investor Contact: Leah
Gibson Vice President, Investor Relations &
Corporate Communications Vigil Neuroscience,
Inc. lgibson@vigilneuro.com
Media Contact: Megan McGrath CTD
Comms, LLC megan@ctdcomms.com
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