Vigil Neuroscience, Inc. announced that it has received notification from the U.S. Food and Drug Administration regarding its Investigational New Drug application to evaluate the Company?s oral small molecule TREM2 agonist VG-3927. The IND for VG-3927 is now open and the Company?s Phase 1 clinical trial in healthy volunteers is allowed to proceed with a partial clinical hold related to maximum exposure limit. At this time, the Company does not anticipate any delay in the current clinical development plans for VG-3927 and expects to commence dosing of the Phase 1 trial evaluating VG-3927 in healthy volunteers in October 2023.

Per the notification, the FDA has limited the maximum exposure of VG-3927 in healthy volunteers in the planned Phase 1 clinical trial. Based on preclinical studies, the Company believes that the maximum exposure limit exceeds the predicted efficacious dose of VG-3927. From the initial comments received from the FDA, the Company believes that the partial clinical hold was not a result of any preclinical toxicology findings or TREM2 pharmacology.

The Company expects to receive additional details from the FDA within the next 30 days and will work closely with the FDA to address the partial clinical hold.