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Amylyx Pharmaceuticals Announces Oral Presentation of Safety and Tolerability Data on AMX0035 from Clinical Trials at 2022 American Academy of Neurology Annual Meeting
- Summary of data from CENTAUR and PEGASUS showed AMX0035 was safe and well tolerated in clinical trials in amyotrophic lateral sclerosis (ALS) and
About this update from Amylyx Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Summary of data from CENTAUR and PEGASUS showed AMX0035 was safe and well tolerated in clinical trials in amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease (AD)\n\n- Majority of treatment-emergent adverse events (TEAEs) associated with AMX0035 were gastrointestinal in both trials with no new safety signals identified\n\n- Findings help further clarify the safety profile of AMX0035\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAmylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the presentation of safety and tolerability data on AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) as assessed in the CENTAUR and PEGASUS clinical trials in participants with amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease (AD), respectively. The data support the overall safety profile of AMX0035 as findings from this analysis show adverse event incidence was generally similar between AMX0035 and placebo groups in both sets of trial participants.\n\n“The results of this analysis provide additional insights and clarifications on the overall safety and tolerability of AMX0035 in people with two different conditions, ALS and AD, and how these diseases might impact the results,” said Sabrina Paganoni, M.D., Ph.D., principal investigator of the CENTAUR trial, investigator at the Healey & AMG Center for ALS at Massachusetts General Hospital and Associate Professor of PM&R at Harvard Medical School and Spaulding Rehabilitation Hospital. “The comparison of TEAEs across both the CENTAUR and PEGASUS clinical trials suggests the higher overall incidence of TEAEs in CENTAUR trial participants, including muscular weakness and falls, could be attributed to the natural progression of ALS, as they were not observed in people with AD.”\n\nIn the CENTAUR trial participants (AMX0035, n=89; placebo, n=48) completing the 24-week randomized phase were eligible to enroll in an open-label extension phase and receive AMX0035 (≤132 weeks, week 24 reported). PEGASUS was a 24-week randomized trial in adults with AD or mild cognitive impairment (AMX0035, n=51; placebo, n=44). Evaluation of AMX0035’s safety and tolerability was the primary objective of both trials. Results of the summary of the clinical trials showed that:\n\n\nThe majority of TEAEs associated with AMX0035 were gas...