Amylyx Pharmaceuticals Inc. has announced the initiation of the LUMINA clinical trial, a Phase 1, multinational, randomized, double-blind, placebo-controlled study aimed at evaluating the safety and biological activity of its investigational drug, AMX0114, in individuals with amyotrophic lateral sclerosis (ALS). The trial will involve approximately 48 participants who will be randomized in a 3:1 ratio to receive either AMX0114 or placebo through intrathecal administration every four weeks, for a total of up to four doses. The study will also assess changes in ALS biomarkers, such as neurofilament light (NfL) levels. In conjunction with the trial, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AMX0114, which targets calpain-2, a contributor to axonal degeneration in ALS. Early data from the trial's cohorts are anticipated in 2025.
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