Vigil Neuroscience receives positive opinion from EMA on ODD for VGL101

Vigil Neuroscience announced that the Committee for Orphan Medicinal Products, COMP, of the European Medicines Agency, EMA, has issued a positive opinion on the Company’s application for orphan drug designation, ODD, for VGL101 for the treatment of CSF1R-related leukoencephalopathy, which includes adult-onset leukoencephalopathy with axonal spheroids and pigmented glia, ALSP. The Company is currently evaluating VGL101 in a Phase 2 proof-of-concept trial in patients with ALSP. VGL101 was previously granted orphan drug designation by the U.S. Food and Drug Administration for ALSP in July 2022. “Receiving a positive opinion for orphan drug designation for VGL101 in the EU is a tremendous achievement in our efforts to develop a therapy for individuals living with ALSP, which affects approximately 13,000 people in the EU,” said Ivana Magovevi-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil. “ALSP is a rare and rapidly progressive neurodegenerative disease with no approved treatment. We are committed to advancing our program through clinical development and bringing this potentially transformative therapy to these patients as quickly as possible.”