Vigil Neuroscience Presents VGL101 Complete Phase 1 Data and Phase 2 IGNITE Trial Design at the 2023 American Neurological Association Annual Meeting
11 Septembre 2023 - 6:00PM
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 the complete data analysis from its VGL101 Phase 1 single
and multiple ascending dose (SAD and MAD) healthy volunteer trial
in a poster presentation at the 2023 American Neurological
Association (ANA) Annual Meeting. In addition, the Company
presented a poster highlighting the study design for its ongoing
IGNITE Phase 2 clinical trial.
“The dataset from the VGL101 Phase 1 healthy
volunteer trial is very encouraging and further validates our
development strategy for the ongoing IGNITE Phase 2 trial in ALSP.
VGL101 continued to demonstrate a favorable safety and tolerability
profile and remains the first antibody to show durability of TREM2
engagement in a clinical setting,” said Ivana Magovčević-Liebisch,
Ph.D., J.D., President and Chief Executive Officer of Vigil. “We
are committed to achieving further milestones for VGL101, including
the interim data readout from IGNITE in the fourth quarter of 2023.
The IGNITE interim analysis will be the first ever clinical data
provided from an interventional study in ALSP.”
The Phase 1 SAD and MAD trial was designed to
assess the safety, tolerability, pharmacokinetics (PK) and
pharmacodynamics (PD) of VGL101 in healthy volunteers. The trial
enrolled 136 healthy volunteers who received either VGL101 (n=113)
at fixed single doses ranging from 1 to 60 mg/kg or three ascending
doses ranging from 20 to 60 mg/kg, or placebo (n=23). An interim
safety analysis of VGL101 for the 1 mg/kg to 40 mg/kg SAD cohorts
and data for the 20 mg/kg MAD cohort were previously disclosed in
November 2022.
Highlights from the VGL101 Phase 1 healthy
volunteer trial presented at the ANA Annual Meeting include:
- VGL101 demonstrated a favorable
safety and tolerability profile in SAD and MAD cohorts at doses up
to 60 mg/kg.
- VGL101 showed linear and
predictable pharmacokinetic characteristics and an observed
half-life that supports monthly dosing.
- The Phase 1 cerebrospinal fluid
(CSF) biomarker data demonstrated pharmacologic activity across
multiple measures:
- Demonstrated proof-of-target
engagement based on dose-dependent, robust and durable reductions
in soluble TREM2 (sTREM2) following repeat dosing.
- Increased soluble CSF1R (sCSF1R)
and osteopontin levels were durable following repeat dosing
indicating that VGL101 impacted microglial activity downstream of
TREM2 target engagement.
- Target engagement and downstream
pharmacodynamic responses of VGL101 at 20 mg/kg and 40 mg/kg
support evaluating these doses in the ongoing IGNITE Phase 2 trial
in ALSP patients.
In a separate poster at the ANA Annual Meeting,
the Company presented the trial design for its ongoing Phase 2
IGNITE trial. IGNITE is a global, open-label clinical trial
evaluating VGL101 in approximately 15 patients with symptomatic
ALSP who have a confirmed CSF1R gene mutation. As part of the
protocol, patients will receive an intravenous (IV) infusion of
VGL101 at 20 mg/kg or 40 mg/kg approximately every four weeks, for
a treatment duration of one year. The primary objective of the
IGNITE trial is to evaluate the safety and tolerability of VGL101.
Secondary objectives include evaluating the impact of VGL101 on
magnetic resonance imaging (MRI) and its pharmacodynamic effect on
fluid biomarkers in patients with symptomatic ALSP. Clinical
efficacy outcome measures are also being collected as exploratory
endpoints. In the fourth quarter of 2023, the Company expects to
report interim 6-month data from the IGNITE trial in the first 6
patients who have received 20 mg/kg of VGL101.
The posters can be accessed on
the Publications page of the Company’s website.
About VGL101VGL101, Vigil’s
lead product 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. VGL101 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 ALSPALSP is a rare,
inherited, autosomal dominant neurological disease with high
penetrance. It is caused by a mutation to the CSF1R gene and
affects an estimated 10,000 people in the US, with similar
prevalence in Europe and Japan. The disease generally presents in
adults in their forties, is diagnosed through genetic testing and
established clinical/radiologic criteria and is characterized by
cognitive dysfunction, neuropsychiatric symptoms, and motor
impairment. These symptoms typically exhibit rapid progression with
a life expectancy of approximately six to seven years on average
after diagnosis, causing significant patient and caregiver burden.
There are currently no approved therapies for the treatment of
ALSP, underlining the high unmet need in this rare indication.
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 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 progress
and timing of the clinical development of Vigil’s programs,
including the availability of data and expected timing for
reporting interim data from IGNITE; and the ability and timing to
achieve future developmental, clinical and regulatory milestones
for VGL101. 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 conducting and
reporting data analyses; the uncertainties as to the availability
and timing of results and data from clinical studies; 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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