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Vigil Neuroscience Provides Update on Clinical Development Strategy to Pursue Potential Accelerated Approval Pathway for Iluzanebart in ALSP
Vigil Neuroscience (Nasdaq: VIGL) has updated its clinical development strategy for iluzanebart in adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP)following a Type C Meeting with the FDA.
The company will preserve the IGNITE dataset for a final analysis at 12 months, foregoing an interim analysis. This approach aims to leverage their biomarker strategy and pursue a potential accelerated approval pathway.
The FDA has shown openness to considering accelerated approval, requesting additional data to support the proposed development plan.
Vigil plans to report the final analysis from the IGNITE clinical trial in the first half of 2025, including all patients dosed with either 20 mg/kg or 40 mg/kg of iluzanebart over 12 months.
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