Exhibit 99.1
Vigil Neuroscience Provides Update on Clinical Development Strategy to Pursue Potential Accelerated
Approval Pathway for Iluzanebart in ALSP
WATERTOWN, Mass., July 18, 2024 (GLOBE NEWSWIRE) Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage
biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, announced today an update following a Type C Meeting with the U.S. Food and Drug Administration (FDA) to its clinical development
strategy for its IGNITE clinical trial evaluating iluzanebart in people with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP).
We are updating our clinical development strategy to preserve the IGNITE dataset for a final analysis at 12 months, which we believe provides the best
opportunity to leverage our biomarker strategy and to pursue the potential accelerated approval pathway. As part of this strategy, we will not conduct an interim analysis prior to the study completion, said Ivana Magovčević-Liebisch,
Ph.D., J.D., President and Chief Executive Officer of Vigil. This follows a Type C meeting with the FDA where the Agency stated that it was open to considering the accelerated approval pathway and that we should provide additional data to
support our proposed development plan. We look forward to continuing to engage with the FDA as we work to bring this potential therapy to patients in need as quickly as possible.
The Company plans to report the final analysis from the IGNITE clinical trial, including all patients at 12 months dosed with either 20 mg/kg or 40 mg/kg of
iluzanebart in the first half of 2025.
About IGNITE Clinical Trial
IGNITE is a global Phase 2 clinical trial to evaluate iluzanebart as a treatment for symptomatic ALSP patients who have a confirmed CSF1R gene mutation.
Patients enrolled in the trial receive an intravenous (IV) infusion of iluzanebart at 20 mg/kg or 40 mg/kg approximately every four weeks for a treatment duration of one year. The trial is evaluating safety, biomarker endpoints, including
magnetic resonance imaging (MRI) and neurofilament light chain (NfL), and clinical endpoints using standard cognitive, motor and functional assessments.
About Iluzanebart
Iluzanebart, Vigils lead
clinical 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. Iluzanebart 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.