Vigil Neuroscience announces FDA lifts partial clinical hold on VGL101

Vigil Neuroscience announced that the U.S. Food and Drug Administration has lifted its partial clinical hold on doses greater than 20 mg/kg for VGL101 in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia. VGL101, Vigil’s lead product candidate, is currently being studied in IGNITE, a Phase 2 proof-of-concept trial in patients with ALSP as well as in an ongoing Phase 1 single and multiple ascending dose healthy volunteer trial. In November 2022, Vigil reported interim top-line data from the Phase 1 trial in healthy volunteers in the United States and Australia. Based on these data, VGL101 demonstrated favorable safety and tolerability profiles at doses up to 40 mg/kg SAD and 20 mg/kg MAD. The Company expects to report the full data analysis up to 60 mg/kg from the Phase 1 trial in the second half of 2023. In December 2022, Vigil initiated a Phase 2 proof-of-concept clinical trial evaluating VGL101 in patients with ALSP. IGNITE, the first interventional trial in ALSP, is a global Phase 2, open-label trial designed to evaluate the safety and tolerability of VGL101 in up to 15 patients with symptomatic ALSP who have a CSF1R gene mutation. Patients enrolled in the trial will receive an intravenous infusion of 20 mg/kg of VGL101 approximately every 4 weeks for a treatment duration of one year. The Company expects to report six-month interim data from the first six patients in this trial in the second half of 2023. The FDA previously granted Fast Track designation and Orphan Drug designation to VGL101 for the treatment of ALSP.