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Amylyx Pharmaceuticals to Announce Plans for an Open Label Extension (OLE) Phase for Global PHOENIX Trial of AMX0035 in ALS at the 17th International Congress on Neuromuscular Diseases
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced a poster on the ongoing
About this update from Amylyx Pharmaceuticals, Inc.
[{"type":"text","content":" CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAmylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced a poster on the ongoing international Phase 3 PHOENIX trial (study A35-004, NCT05021536) of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) in people living with amyotrophic lateral sclerosis (ALS) will be presented on Saturday, July 9, at the 17th International Congress on Neuromuscular Diseases (ICNMD 2022) in Brussels, Belgium. The poster will include an overview of the PHOENIX trial design and methodology, as well as an update on a planned open-label extension (OLE) phase for PHOENIX.\n\n“The Phase 3 PHOENIX trial is enrolling a larger and broader group of people living with ALS than were enrolled in the Phase 2 CENTAUR trial, helping us to generate additional data on potential treatment effects of AMX0035,” said Leonard H. van den Berg, M.D., Ph.D., Professor of Neurology at UMC Utrecht in the Netherlands and Chairman of the Treatment Research Initiative to Cure ALS (TRICALS), a large European trial network dedicated to finding effective treatments for ALS. “We look forward to sharing our plans for the OLE phase at ICNMD.”\n\nPresentation Details:\n\nTitle: International Phase 3 Trial Evaluating Sodium Phenylbutyrate and Taurursodiol in Amyotrophic Lateral Sclerosis (PHOENIX) \nPoster Number: 11 \nDate: Saturday, July 9, 2022 \nTime: 12:45-2:15 p.m. CEST\n\nAbout AMX0035\n\nAMX0035 (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication approved with conditions as ALBRIOZA™ to treat amyotrophic lateral sclerosis (ALS) in Canada and with marketing applications pending in the United States and European Union. The combination of sodium phenylbutyrate and taurursodiol may reduce neuronal cell death, hypothesized to occur by simultaneously mitigating endoplasmic reticulum (ER) stress and mitochondrial dysfunction. AMX0035 is also being explored for the potential treatment of other neurodegenerative diseases.\n\nAbout the PHOENIX Trial\n\nThe Phase 3 PHOENIX clinical trial (NCT05021536) is a 48-week, randomized placebo-controlled global clinical trial further evaluating the safety and efficacy of AMX0035 (sodium phenylbutyrate and taurursodiol) for the treatment of ALS. The primary efficacy outcome of the trial will be a composite measure of...