114: Phase 3 PHOENIX Study, AMX0035, and Amylyx's Future Drug Development

NeurologyLive® Mind Moments®

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In this episode, Justin Klee and Josh Cohen, cofounders and cochief executive officers of Amylyx Pharmaceuticals, sat down at the recently concluded AAN Annual Meeting to discuss the results from the pivotal phase 3 PHOENIX trial (NCT) of AMX0035 (Relyvrio) in patients with amyotrophic lateral sclerosis (ALS). The duo provided clarity on the findings, positive takeaways from the disappointing data, and the lessons learned in ALS drug development. In addition, the two provided commentary on the future plans of the therapy in other tauopathies like progressive supranuclear palsy and neurologic conditions like Wolfram syndrome. Furthermore, Klee and Cohen shared thoughts on the company's drug pipeline, including AMX0114, an antisense oligonucleotide in development for patients with ALS.
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Episode Breakdown:

• 1:05 – Decision behind removing AMX0035 from market
• 3:00 – Lessons from PHOENIX, AMX0035 drug development program
• 6:45 – Unraveling PHOENIX study data
• 10:00 – Neurology News Minute
• 12:10 – Potential of AMX0035 in other tauopathies, neurologic conditions
• 15:00 – Outlook of antisense oligonucleotide AMX0114 in ALS

The stories featured in this week's Neurology News Minute, which will give you quick updates on the following developments in neurology, are further detailed here:

• Diazepam Buccal Film’s Role in Treating Intermittent Pediatric Seizures, with Michael Rogawski, MD, PhD

• Ocrelizumab Gains EU CHMP Positive Opinion for Subcutaneous Formulation to Treat MS

• FDA Approves Sprinkle Formulation of Neurocrine Biosciences’ Valbenazine for Tardive Dyskinesia or Huntington disease Chorea

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