Vigil Neuroscience Provides 2023 Year-in-Review and Highlights Upcoming 2024 Milestones
January 03 2024 - 4:30PM
Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage
biotechnology company committed to harnessing the power of
microglia for the treatment of neurodegenerative diseases, today
provided a 2023 year-in-review and outlined key milestones
anticipated in 2024. The Company also today announced that it has
extended its projected cash runway into the second half of 2025.
“2023 marked a year of persistent advancement
and landmark achievements for the Company,” said Ivana
Magovčević-Liebisch, Ph.D., J.D., President and Chief Executive
Officer of Vigil. “Most notably, we were the first company to
demonstrate clinical data supporting TREM2 agonism as a potential
therapeutic approach in neurodegenerative disease. We accomplished
another first when we commenced dosing in our Phase 1 healthy
volunteer clinical trial evaluating VG-3927, the only small
molecule TREM2 agonist in the clinic for the potential treatment of
Alzheimer’s disease.”
Key Clinical Program Highlights for
2023
Iluzanebart (VGL101): A fully human
monoclonal antibody candidate targeting human triggering receptor
expressed on myeloid cells 2 (TREM2)
-
Completed Phase 1 clinical trial of iluzanebart and reported data
from single and multiple ascending dose (SAD and MAD) cohorts in
healthy volunteers, which demonstrated that iluzanebart continued
to have a favorable safety and tolerability profile and showed
proof-of-target engagement in SAD/MAD cohorts up to 60 mg/kg.
-
Granted orphan drug designation for iluzanebart from the European
Commission for the treatment of colony stimulating factor 1
receptor (CSF1R)-related leukoencephalopathy, which includes
ALSP.
- Reported
positive interim data from Phase 2 IGNITE proof-of-concept clinical
trial of iluzanebart in ALSP. These data highlighted a favorable
safety and tolerability profile and demonstrated clear CNS target
engagement and downstream pharmacological activity and
directionally supportive changes in individual patients at 6 months
on magnetic resonance imaging (MRI) and neurofilament light chain
(NfL) biomarkers.
-
Reported findings from its ongoing natural history study,
ILLUMINATE, which continued to provide critical insights on MRI and
NfL biomarkers and support soluble CSF1R (sCSF1R) as a potential
key biomarker of ALSP disease pathology.
-
Based on the totality of the data reported in 2023 from the
ILLUMINATE and IGNITE studies, the Company plans to engage with the
U.S. Food and Drug Administration (FDA) in the first half of 2024
regarding a potential accelerated development pathway for
iluzanebart in ALSP.
VG-3927: A highly active, selective, and
brain-penetrant small molecule TREM2 agonist
-
Received notification from the FDA that the Investigational New
Drug (IND) application for VG-3927 was open and the Phase 1
clinical trial evaluating VG-3927 in healthy volunteers was allowed
to proceed with a partial clinical hold related to maximum exposure
limit. The Company is in the process of obtaining additional PK
data and will work with the FDA to address the partial clinical
hold. Based on preclinical studies, the Company believes that the
maximum exposure limit exceeds the predicted efficacious dose of
VG-3927.
-
Dosed its first participant in the Phase 1 clinical trial of
VG-3927 in healthy volunteers, making it the first and only small
molecule TREM2 agonist in the clinic for the potential treatment of
Alzheimer’s disease.
Key Corporate Highlights for
2023
- Launched
ALSPAware, a new program providing no-cost genetic testing and
counseling services for the diagnosis of ALSP.
Corporate Update & 2024 Anticipated
Milestones
-
The Company has extended its projected cash runway into the second
half of 2025 by focusing its financial resources on current
business priorities, including its iluzanebart and VG-3927 clinical
development programs. The Company’s reallocation of capital is not
expected to have any impact on employee headcount or anticipated
development milestones.
-
Vigil is on track to report interim data from the ongoing Phase 1
clinical trial of VG-3927 in healthy volunteers in mid-2024.
-
The Company expects to report Phase 2 results from its IGNITE
clinical trial evaluating iluzanebart in ALSP from all patients
(n=15) at 6 months at both 20 mg/kg and 40 mg/kg doses in the third
quarter of 2024.
“We enter 2024 well-positioned to achieve our
planned value-driving milestones across our development pipeline,”
concluded Dr. Magovčević-Liebisch. “We are confident in our ability
to continue executing on our precision medicine strategy while
thoughtfully allocating financial resources to best support our
current development programs and our commitment to our patient
communities.”
J.P. Morgan Healthcare Conference
Details
The Company today announced that Dr.
Magovčević-Liebisch will present at the 42nd Annual J.P. Morgan
Healthcare Conference on Thursday, January 11, 2024, at 7:30 a.m.
PT / 10:30 a.m. ET.
To register for the live event, please click
here. The live webcast will also be available on the Company’s
website on the “Events & Presentations” page in the “Investors”
section. An archived webcast will be available for approximately 90
days following the presentation.
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) in genetically defined subpopulations.
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
Company’s strategy, business plans and focus; the progress and
timing of the clinical development of Vigil’s programs, including
the availability of, and expected timing for reporting, data from
both the IGNITE Phase 2 clinical trial and the VG-3927 Phase 1
clinical trial; expectations regarding the VG-3927 partial clinical
hold; beliefs that the maximum exposure limit for VG-3927 exceeds
the predicted efficacious dose; the success and timing of the
Company’s interactions with regulatory authorities; beliefs about
the ability of the Company to execute on strategy and efficiently
allocate financial resources and extend the Company’s cash runway
into the second half of 2025. 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 identification and development of product
candidates, including the conduct of research activities and the
conduct of clinical trials; uncertainties as to the availability
and timing of results and data from 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; the Company’s ability to work with the FDA to
successfully remove the partial clinical hold on VG-3927; whether
Vigil’s cash resources will be sufficient to fund its foreseeable
and unforeseeable operating expenses and capital expenditure
requirements; 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 September 30, 2023 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
MacDougall Advisorsmmcgrath@macdougall.bio
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