ASA Monitor November 2023, Vol. 87, 18.
Vigil Neuroscience’s Alzheimer’s drug given FDA green light, with a partial clinical hold
Vigil Neuroscience has been granted clearance from the FDA to launch an early-stage Alzheimer’s trial, but that approval comes with strings attached: a partial clinical hold.
The FDA has approved Vigil’s investigational new drug application for VG-3927, a small molecule TREM2 agonist for Alzheimer’s in genetically defined subpopulations. The move allows Vigil to launch a phase 1 clinical trial in healthy volunteers, though the FDA implemented a partial clinical hold tied to the maximum exposure limit of VG-2927.
Vigil didn’t share what the limit cited by the FDA was but believes it is higher than the predicted efficacious dose of VG-3927, as based on preclinical models. The company plans to start dosing next month.
Based on initial comments from the regulatory agency, Vigil doesn’t think the partial hold was a result of any preclinical toxicology findings or TREM2 pharmacology, according to the September 9 release. Such findings recently led to the discontinuation of Denali Therapeutics’ TREM2-targeting candidate DNL919. The Takeda-partnered asset was being assessed in a phase 1 trial that the FDA had placed a hold on after safety signals of moderate, reversible hematologic effects were observed at the highest dose.
Source: asamonitor.pub/3ZdTAka