Amylyx publishes ITT survival analysis of Centaur to historical control

Amylyx Pharmaceuticals, announced the publication of a post hoc analysis in the peer-reviewed medical journal, Annals of Clinical and Translational Neurology comparing the long term survival of participants in the CENTAUR study versus a historical clinical trial control group. The results of this post hoc analysis, which demonstrated that the median overall survival was 10.4 months longer in the CENTAUR AMX0035 group than in the historical clinical trial control group, are consistent with the data previously presented at the 2023 American Academy of Neurology Annual Meeting. A previously reported intent-to-treat ITT overall survival analysis comparing participants originally randomized to AMX0035 versus participants originally randomized to placebo demonstrated a 4.8 month longer survival for the AMX0035 group. However, this ITT analysis did not account for the fact that 71% of participants originally randomized to placebo received AMX0035 during the OLE phase of the trial, which may lead to an underestimation of the effect of AMX0035 on survival. The post hoc survival analysis published today compared CENTAUR clinical trial participants who received AMX0035 against a propensity score-matched, AMX0035-naive external control cohort from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database. The results demonstrated a longer survival and a 52% lower risk of death over the duration of follow-up in the CENTAUR AMX0035 group versus the PRO-ACT external control group. These results using an external control aligned with prior analysis using statistical models adjusting for placebo-to-active crossover in CENTAUR RPSFTM .