Amylyx Pharmaceuticals Announces Completion of Enrollment in Global Phase 3 PHOENIX Trial of AMX0035 in ALS - Seite 2

“We are grateful for the people living with ALS and their families who are participating in PHOENIX and the dedication of the study investigators,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx. “We remain committed to continuing research and exploring the full potential of AMX0035 as part of our mission to one day end the suffering caused by ALS and other neurodegenerative diseases.”

Marketing Application Reviews

The European Medicines Agency (EMA) is reviewing the submission of the Company’s Marketing Authorisation Application for AMX0035 for the treatment of ALS in Europe. The Company anticipates a decision from the EMA in the first half of 2023. It is expected that the ongoing Phase 3 PHOENIX clinical trial will be part of the obligations of the conditional marketing authorization if granted.

In Canada, AMX0035 (marketed as ALBRIOZA) was approved under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. One of the conditions of the approval is the provision of data from the Phase 3 PHOENIX trial.

About AMX0035

AMX0035 is an oral, fixed-dose medication approved to treat amyotrophic lateral sclerosis (ALS) in adults in the U.S. as RELYVRIO (sodium phenylbutyrate and taurursodiol) and approved with conditions in Canada as ALBRIOZA (sodium phenylbutyrate and ursodoxicoltaurine). Additionally, the European Medicines Agency (EMA) is reviewing the Company’s Marketing Authorisation Application for AMX0035 for the treatment of ALS in Europe. AMX0035 is being explored for the potential treatment of other neurodegenerative diseases.

About ALS

ALS is a relentlessly progressive and fatal neurodegenerative disorder caused by motor neuron death in the brain and spinal cord. Motor neuron loss in ALS leads to deteriorating muscle function, the inability to move and speak, respiratory paralysis and eventually, death. More than 90% of people with ALS have sporadic disease, showing no clear family history. ALS affects approximately 29,000 people in the U.S. and more than 30,000 people are estimated to be living with ALS in Europe (European Union and United Kingdom). People living with ALS have a median survival of approximately two years from diagnosis.