eClinical Technology and Industy News

Amylyx Pharmaceuticals Announces Publication of Data Showing Randomization to AMX0035 Prolonged Tracheostomy/Ventilation-free Survival and Reduced Occurrence of First Hospitalization

  • Adding to previously reported overall functional and survival benefit data for AMX0035, these findings support effect of AMX0035 on disease progression in ALS
  • Randomization to AMX0035 resulted in a lower occurrence of death or tracheostomy/permanent assisted ventilation by 49% and first hospitalization by 44% over the Phase 2 trial and duration of follow-up

Excerpt from the Press Release:

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the publication of long-term prespecified analyses assessing the occurrence of key events in addition to death from the Phase 2 CENTAUR trial including tracheostomy, permanent assisted ventilation (PAV), and first hospitalization. Data analyses demonstrated that early administration of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) resulted in a lower occurrence of tracheostomy/PAV and delayed first hospitalization during the trial and follow-up period in participants with amyotrophic lateral sclerosis (ALS). These results are published in the peer-reviewed medical journal, Journal of Neurology, Neurosurgery and Psychiatry.

“People living with ALS often require medical interventions like mechanical ventilation as the disease progresses and impacts the muscles of respiration,” said Sabrina Paganoni, M.D., Ph.D., principal investigator of the CENTAUR trial, investigator at the Sean M. Healey & AMG Center for ALS at Mass General and Associate Professor of PM&R at Harvard Medical School and Spaulding Rehabilitation Hospital. “These interventions come at a great cost, both personally and financially, for people living with the disease and developing therapies that can help delay these interventions can have a positive impact on their lives.”

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