Vigil Neuroscience, Inc. announced that the U.S. Food and Drug Administration (FDA) 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 (ALSP). VGL101, the Company'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 (SAD and MAD) healthy volunteer trial. FDA has lifted the partial clinical hold on VGL101 based on supporting clinical data from the ongoing Phase 1 trial, said Ivana Magov evi -Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil.

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.

The FDA previously granted Fast Track designation and Orphan Drug designation to VGL101 for the treatment of ALSP.