Exhibit 99.1
Vigil Neuroscience Announces FDA Has Removed Partial Clinical Hold on
VG-3927
WATERTOWN, Mass. – September 17, 2024 – 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 U.S. Food and Drug Administration (FDA) has removed the partial clinical
hold on its ongoing Phase 1 clinical trial of VG-3927. The FDA’s decision was based on a complete response submitted by the Company.
“We are pleased with the resolution of the partial clinical hold – a decision that was supported by
non-clinical and clinical data from our ongoing Phase 1 trial,” said Petra Kaufmann, M.D., F.A.A.N., Chief Medical Officer at Vigil. “While the partial clinical hold did not delay clinical
development of VG-3927, the option to increase the exposure limit provides us the best opportunity to explore the full pharmacology of VG-3927 as a potentially novel,
next generation therapy for those living with Alzheimer’s disease.”
In July 2024, the Company reported interim data from the ongoing Phase 1
single- and multiple-ascending dose clinical trial evaluating VG-3927 in healthy volunteers. These data showed that the safety and tolerability profile observed in individual doses in six SAD and two MAD
cohorts supported continued clinical development of VG-3927. In addition, VG-3927 demonstrated a predictable PK profile supportive of once-daily dosing. Importantly, VG-3927 achieved a robust and sustained decrease of soluble TREM2 in the CSF demonstrating clinical proof-of-target engagement. VG-3927 also showed an increase in osteopontin/secreted phosphoprotein 1 (SPP1) after repeat dosing.
As part of the
Phase 1 clinical trial, the Company has initiated dosing of a cohort of Alzheimer’s disease patients, including some participants who carry TREM2 or other disease-related variants to explore the biomarker response of VG-3927 after a single dose. Vigil expects to use these data to inform the development strategy for subsequent and larger trials evaluating VG-3927 in AD. The Company plans to
report the complete Phase 1 clinical data, including data from the AD patient cohort, in the first quarter of 2025.
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.