Business
RELYVRIO® and AMX0114 Data to be Presented at 34th International Symposium on ALS/MND
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that several abstracts detailing
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 that several abstracts detailing data on AMX0035 (sodium phenylbutyrate and taurursodiol [PB&TURSO]) and the Company’s investigational antisense oligonucleotide, AMX0114, for the potential treatment of amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases will be presented at the 34th International Symposium on ALS/MND. New data using a model for assessing mortality-adjusted progression (MAP) for clinical trials of ALS and encore posters will be presented.\n\n\nDetails of the poster presentations are as follows:\n\n\nWednesday, December 6, 2023, Session A, 5:45 – 7:30 p.m. CET\n\n\n\nTitle: A Joint Model for Assessing Mortality-Adjusted Progression (MAP) in Amyotrophic Lateral Sclerosis: Application to Clinical Trials of Sodium Phenylbutyrate and Taurursodiol\nThis poster features an overview of the MAP model, a method that has been developed by leading ALS clinicians and statisticians and detailed in previous publications as an approach to account for deaths, while providing an interpretable and clinically relevant ALS Functional Rating Scale–Revised (ALSFRS-R) result. Results from a post hoc analysis of the Phase 2 CENTAUR trial using this model are presented, which resulted in a nearly identical statistical outcome with increased precision as the primary analysis. The Company intends to use a similar model for the primary efficacy analysis in the ongoing Phase 3 PHOENIX trial, with results anticipated in the second quarter of 2024.\nPoster Number: CLT-30\n\n\n\n\nTitle: Ongoing and Planned Studies to Further Elucidate the Efficacy, Safety, and Pharmacokinetics of Sodium Phenylbutyrate and Taurursodiol in Amyotrophic Lateral Sclerosis (encore)\nThis poster outlines studies currently underway that further assess efficacy and safety of AMX0035 in people living with ALS, including in real-world settings.\nPoster Number: CLT-10\n\n\n\n\nTitle: Development of a Composite Diagnostic Biomarker for Amyotrophic Lateral Sclerosis: Experimental Approach and Progress to Date (encore)\nOne of the key drivers of diagnostic delay in ALS is the lack of reliable, validated biomarkers to aid in diagnosis. This poster provides an update on the progress made in developing a biomarker test that could make...