FDA lifts clinical hold on Amylyx’s Phase I ALS trial

FDA lifts clinical hold from Phase 1 trial of Amylyx's ALS therapy...

The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on a Phase 1 clinical trial that’s testing AMX0114, Amylyx Pharmaceuticals’ investigational treatment for amyotrophic lateral sclerosis (ALS). The hold came in November after Amylyx asked to initiate the first-in-human studies for AMX0114 at a starting dose of 12.5 mg. The FDA restricted dosing to an amount lower than that and asked additional questions, resulting in the re…

Amylyx Pharmaceuticals gets FDA go ahead for phase 1 ALS trial

The Massachusetts based biotech will now press ahead with human trials for its antisense oligonucleotide (ASO) therapy, designed to treat amyotrophic lateral sclerosis (ALS), after the FDA lifted its clinical hold on the trial.

FDA lifts clinical hold on Amylyx’s Phase I ALS trial

Amylyx will be allowed to run a Phase I trial after the FDA lifted a clinical hold of its investigational ALS drug.The post FDA lifts clinical hold on Amylyx’s Phase I ALS trial appeared first on Clinical Trials Arena.