Vigil Neuroscience Announces First Participant Dosed in Phase 1 Clinical Trial in Healthy Volunteers Evaluating VG-3927, a Small Molecule TREM2 Agonist, for Potential Treatment of Alzheimer’s Disease
October 17 2023 - 7:05AM
Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage
biotechnology company committed to harnessing the power of
microglia for the treatment of neurodegenerative diseases, today
announced that the Company has dosed its first participant in a
Phase 1 clinical trial in healthy volunteers evaluating VG-3927,
the first and only small molecule TREM2 agonist in the clinic for
the potential treatment of Alzheimer’s disease (AD).
“Dosing the first participant in our Phase 1
trial of VG-3927, the first and only small molecule TREM2 agonist
in clinical development for assessment in AD, is an important
milestone in our multi-modality strategy to develop novel
therapeutics for the treatment of rare and common neurodegenerative
diseases,” said Ivana Magovčević-Liebisch, Ph.D., J.D., President
and Chief Executive Officer of Vigil. “With approximately 6.7
million Americans living with AD, there remains a significant need
for new therapies with improved safety and efficacy and that can
broadly address multiple aspects of AD disease pathophysiology. Our
orally bioavailable and highly CNS penetrant TREM2 agonist VG-3927
has a differentiated mechanism of action with multiple potential
therapeutic advantages in AD, and we are excited to advance VG-3927
to potentially bring a differentiated treatment option to AD
patients.”
The double-blind, placebo-controlled Phase 1
clinical trial plans to evaluate VG-3927 in SAD (single) and MAD
(multiple) ascending dose cohorts in healthy volunteers. The study
is designed to evaluate VG-3927’s safety and tolerability,
pharmacokinetics (PK), and pharmacodynamics (PD). The Company
anticipates reporting interim Phase 1 topline data in mid-2024.
About VG-3927Vigil’s highly
active, selective, and brain-penetrant small molecule TREM2
agonist, VG-3927, is designed to act as a molecular glue that
potentiates the TREM2 signaling response to natural damage ligands.
In preclinical studies, Vigil has established that VG-3927
demonstrated on-target TREM2 activation across both common and rare
TREM2 variants. Additionally, VG-3927 demonstrated preclinically
that it was able to deliver in vivo TREM2 responses
within the central nervous system at a magnitude and specificity
similar to VGL101.
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. We
are utilizing the tools of modern neuroscience drug development
across multiple therapeutic modalities in our efforts to develop
precision-based therapies to improve the lives of patients and
their families. VGL101, our 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. We are
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) in
genetically defined subpopulations.
Forward-Looking Statements This
press release includes certain disclosures that contain
“forward-looking statements” of Vigil Neuroscience, Inc.’s (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 our product candidates and the timing and
availability of interim data from VG-3927’s Phase I trial. Factors
that could cause actual results to differ include, but are not
limited to, risks and uncertainties inherent in the development of
therapeutic product candidates, including risks and uncertainties
related to conducting clinical trials; the Company’s ability to
recruit study subjects for clinical trials; the availability and
timing of results and data from clinical trials; and the Company’s
ability to work with the FDA to successfully remove the partial
clinical hold on VG-3927; 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 June 30, 2023 and in any subsequent
filings it may make 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
InformationVigil 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
GibsonVice President, Investor Relations & Corporate
Communications Vigil Neuroscience, Inc.lgibson@vigilneuro.com
Media Contact: Megan
McGrathMacDougall Advisorsmmcgrath@macdougall.bio
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