Vigil Touts Positive Healthy Volunteer Data From Lead Program In Rare Neurological Disease
- Vigil Neuroscience Inc announced interim topline results from its ongoing Phase 1 trial of VGL101, its lead product candidate, in healthy volunteers.
- These interim data support the initiation of a Phase 2 proof-of-concept trial in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) with a 20 mg/kg dose.
- All adverse events (AEs) were mild in severity except for one moderate AE of dizziness, and all AEs resolved without intervention. No serious adverse events have been reported to date.
- VGL101 showed dose-proportional PK with a favorable half-life and brain penetration.
- VGL101 achieved dose-dependent, durable decreases in levels of sTREM2 in the cerebrospinal fluid (CSF), demonstrating proof of target engagement.
- VGL101 20 mg/kg repeat dosing was associated with a robust reduction in sTREM2 levels, and decreases were observed 28 days after the third and final dose.
- The Company continues to dose escalate in its Phase 1 trial in healthy volunteers and has been cleared to initiate a 60 mg/kg cohort in Australia.
- Vigil is on track to initiate the VGL101 Phase 2 trial in ALSP patients with a 20 mg/kg dose this quarter.
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