Amylyx Pharmaceuticals Discontinues ORION Program for AMX0035 in Progressive Supranuclear Palsy After Phase 2b Results
Amylyx Pharmaceuticals Inc. has decided to discontinue the ORION program for AMX0035 in progressive supranuclear palsy (PSP) after Phase 2b trial results showed no significant differences from placebo. The drug was well-tolerated, and the company will now focus on the Phase 3 LUCIDITY trial of avexitide, with enrollment expected to conclude in 2025. Additionally, Amylyx is advancing AMX0035 in Wolfram syndrome and AMX0114 in ALS, with early Phase 1 LUMINA trial data expected in 2025.
Amylyx Pharmaceuticals Inc. has announced its decision to discontinue the ORION program of AMX0035 for adults with progressive supranuclear palsy (PSP). This decision follows results from a Phase 2b trial, which indicated no significant differences between AMX0035 and placebo on primary or secondary outcomes at Week 24. Despite these results, AMX0035 was generally well-tolerated, with safety data consistent with previous studies. Moving forward, Amylyx will focus on advancing the Phase 3 LUCIDITY trial of avexitide, with enrollment expected to conclude in 2025 and topline data anticipated in the first half of 2026. The company is also progressing with the development of AMX0035 in Wolfram syndrome and AMX0114 in ALS, with early data from the Phase 1 LUMINA trial expected in 2025. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amylyx Pharmaceuticals Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250827304923) on August 27, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
