Vigil Neuroscience Provides Update on Iluzanebart Phase 2 IGNITE Trial in ALSP

Core Insights - Vigil Neuroscience, Inc. announced an update on the Phase 2 IGNITE clinical trial for iluzanebart, a monoclonal antibody TREM2 agonist, aimed at treating adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) [1][2] Group 1: Clinical Trial Results - Iluzanebart showed a favorable safety, tolerability, and pharmacokinetic profile in both 20 mg/kg and 40 mg/kg dose cohorts [2] - The Phase 2 IGNITE trial did not demonstrate beneficial effects on biomarker or clinical efficacy endpoints for ALSP patients [2] - As a result of these findings, the Phase 2 long-term extension study is being discontinued [2] Group 2: Company Perspective - The CEO of Vigil expressed gratitude towards the ALSP community for their support during the trial process, despite the disappointing data outcome [3] - The company believes that the data collected from the IGNITE trial and the ILLUMINATE natural history study have increased awareness and understanding of ALSP [3] Group 3: Trial Design and Objectives - The IGNITE trial was a global Phase 2, open-label proof-of-concept study involving 20 patients with symptomatic ALSP and a confirmed CSF1R gene mutation [4] - The primary objective was to evaluate the safety and tolerability of iluzanebart, while secondary measures included assessing its effects on target engagement and biomarkers of disease progression [4] - Patients received intravenous infusions of iluzanebart at 20 mg/kg or 40 mg/kg approximately every four weeks for one year [4] Group 4: Disease Background - ALSP is a rare, inherited neurological disease caused by a mutation in the CSF1R gene, affecting an estimated 19,000 people in the U.S. [5] - The disease typically presents in adults in their forties and is characterized by cognitive dysfunction, neuropsychiatric symptoms, and motor impairment, with a life expectancy of approximately six to seven years post-diagnosis [5] - There are currently no approved therapies for ALSP, highlighting a significant unmet medical need [5] Group 5: Company Overview - Vigil Neuroscience focuses on developing treatments for neurodegenerative diseases by restoring the function of microglia, the brain's immune cells [6] - The company is also developing VG-3927, a novel small molecule TREM2 agonist, targeting common neurodegenerative diseases, initially focusing on Alzheimer's disease [6]