Vigil Neuroscience Announces Update on its Small Molecule TREM2 Agonist Program
2023年9月9日 - 5:05AM
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 it has received notification from the U.S. Food and
Drug Administration (FDA) regarding its Investigational New Drug
(IND) application to evaluate the Company’s oral small molecule
TREM2 agonist VG-3927. The IND for VG-3927 is now open and the
Company’s Phase 1 clinical trial in healthy volunteers is allowed
to proceed with a partial clinical hold related to maximum exposure
limit. At this time, the Company does not anticipate any delay in
the current clinical development plans for VG-3927 and expects to
commence dosing of the Phase 1 trial evaluating VG-3927 in healthy
volunteers in October 2023.
Per the notification, the FDA has limited the
maximum exposure of VG-3927 in healthy volunteers in the planned
Phase 1 clinical trial. Based on preclinical studies, the Company
believes that the maximum exposure limit exceeds the predicted
efficacious dose of VG-3927. From the initial comments received
from the FDA, the Company believes that the partial clinical hold
was not a result of any preclinical toxicology findings or TREM2
pharmacology. The Company expects to receive additional details
from the FDA within the next 30 days and will work closely with the
FDA to address the partial clinical hold.
The Company also announced today that it will
host a virtual R&D event highlighting its small molecule TREM2
agonist program for AD on Wednesday, September 13, 2023, from 7:30
a.m. to 9:00 a.m. ET.
The event will highlight new preclinical data
for VG-3927, discuss current treatment approaches for AD, and
Vigil’s TREM2-focused clinical approach for treating AD guided by
its precision medicine strategy. Vigil’s management team will be
joined by:
- Marco Colonna, M.D., Robert Rock
Belliveau Professor of Pathology & Immunology, Washington
University School of Medicine. Vigil Neuroscience Scientific
Advisory Board Chairman; and,
- Samuel E. Gandy, Ph.D., M.D.,
Mount Sinai Professor of Alzheimer’s Disease Research, Professor of
Neurology & Psychiatry and Associate Director of Mount Sinai
Alzheimer’s Disease Research Center. Past Chairman, National
Medical & Scientific Advisory Council of the Alzheimer’s
Association.
To access the live webcast of this event, please
register here or visit “Events & Presentations” in the
“Investors” section of the Vigil website
at www.vigilneuro.com. An archived replay will be available
for approximately 90 days following the presentation.
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 NeuroscienceVigil
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 StatementsThis
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 timing for
the commencement and dosing of patients in VG-3927’s Phase I trial;
anticipated impact of the partial clinical hold on the Company’s
clinical development plans; regulatory progress, clinical progress
and clinical development plans for VG-3927; and expectations
regarding the timing of additional regulatory information from the
U.S. Food and Drug Administration (“FDA”). 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 risks and uncertainties related to
the initiation and completion of clinical trials; Company’s ability
to commence and recruit study subjects for clinical trials; the
availability and timing of results and data from clinical trials;
the timing and content of additional regulatory information from
the FDA; 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 Gibson Vice President,
Investor Relations & Corporate CommunicationsVigil
Neuroscience, Inc.lgibson@vigilneuro.com
Media Contact:Megan McGrathMacDougall
Advisorsmmcgrath@macdougall.bio
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