Vigil Presents Key Findings from ILLUMINATE & IGNITE Studies in ALSP at the 2024 American Academy of Neurology Annual Meeting

- Findings from ILLUMINATE Natural History Study show that MRI and fluid biomarkers are emerging as key measures of ALSP pathophysiology -

- Positive interim IGNITE Phase 2 data demonstrating iluzanebart (VGL101) as potential disease-modifying therapy for ALSP

WATERTOWN, Mass., April 17, 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, today announced the presentation of multiple oral and poster presentations on the Company’s lead clinical candidate iluzanebart at the 2024 American Academy of Neurology (AAN) Annual Meeting.

“We are excited to see our enthusiasm for iluzanebart matched by clinical leaders in the ALSP community. The interim findings from both the IGNITE Phase 2 and ILLUMINATE Natural History studies support the potential of iluzanebart to become the first, disease-modifying therapy for those living with ALSP,” said Petra Kaufmann, M.D., F.A.A.N, Chief Medical Officer of Vigil. “Both trials have led to an incredible step forward – not only in understanding ALSP disease progression, but also in drawing parallels between biomarkers and correlating clinical outcomes. We look forward to advancing the clinical development of iluzanebart in the hopes of providing a potentially transformative treatment option for those who have been impacted by this devastating disease.”

Oral presentation presented by Zbigniew Wszolek, M.D., Mayo Clinic, Jacksonville: Interim Results on iluzanebart (VGL101) From IGNITE: First Interventional Phase 2 Study in Patients with Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP)

“Vigil’s interim IGNITE data demonstrated that iluzanebart was well-tolerated, and the data suggest a favorable impact on the protein product of the CSF1R gene whose dysfunction is the causal driver of ALSP,” said Zbigniew Wszolek, M.D., consultant in the Department of Neurology at the Mayo Clinic. “Positive trends on MRI measurements support slowing in irreversible neurodegeneration, and to see these signals in patients as early as six months is very encouraging.”

Interim analysis of the Phase 2 IGNITE proof-of-concept, multicenter, open-label study evaluating safety, tolerability, and clinical effects of iluzanebart demonstrated:

• A favorable safety and tolerability profile 
• Predictable pharmacokinetic (PK) profile that is supportive of once-monthly dosing
• CNS target engagement and downstream pharmacological activity, including increased cerebrospinal fluid (CSF) levels of soluble colony-stimulating factor-1 receptor (sCSF1R), which is emerging as a key biomarker of ALSP disease pathophysiology 
• Positive trends consistent with slowing of disease progression on key magnetic resonance imaging (MRI) measures in individual patients
• Encouraging trend emerging on changes in NfL reduction in individual patients