Clinical Hold Lifted on Vigil Neuro’s VGL101

FDA has lifted its partial clinical hold against Vigil Neuroscience and doses greater than 20 mg/kg for VGL101 in clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). The investigational drug 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.

Vigil describes VGL101 as a fully human monoclonal antibody targeting human triggering receptor expressed on myeloid cells 2 (TREM2), which is responsible for maintaining microglial cell function. “TREM2 deficiency is believed to be a driver of certain neurodegenerative diseases,” it says, adding that it is being developed in other neurodegenerative diseases for which this deficiency is thought to be a key driver of the disease pathway.