Vigil Neuroscience Provides 2023 Year-in-Review and Highlights Upcoming 2024 Milestones

- On track to report interim Phase 1 data for VG-3927 in healthy volunteers in mid-2024 and Phase 2 results from IGNITE clinical trial evaluating iluzanebart in ALSP in Q3 2024 -

- Extends projected cash runway into second half of 2025 -

- Company to present at J.P. Morgan Healthcare Conference on January 11, 2024 at 7:30 a.m. PT/10:30 a.m. ET -

WATERTOWN, Mass., Jan. 03, 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 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.