Amylyx Completes Enrollment in PEGASUS Trial of AMX0035 for Alzheimer’s

Amylyx Completes Enrollment in PEGASUS Trial of AMX0035 for Alzheimer’s
Amylyx Pharmaceuticals announced it has completed enrollment for the Phase 2 clinical trial of AMX0035 for treating Alzheimer's disease. The placebo-controlled trial, PEGASUS (NCT03533257), will evaluate the compound's safety and tolerability among patients with late mild cognitive impairment or early dementia due to Alzheimer’s disease. Other study endpoints (goals) include the compound's effects on Alzheimer's biomarkers (methods to measure disease) and on cognitive and functional abilities. Amylyx said it expects to present study data in the first quarter of 2021. The company originally planned to enroll 100 participants, but completed enrollment at 96, all of whom have received their first doses. The trial will last 24 weeks and takes place at 11 sites across the United States. AMX0035 is an oral formulation of sodium phenylbutyrate (PB) and tauroursodeoxycholic-acid (TUDCA). PB helps prevent proteins from unfolding, which can cause their toxic accumulation within nerve cells. TUDCA helps to limit the loss of cellular energy. The Alzheimer’s Association and Alzheimer’s Drug Discovery Foundation provided
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