Amylyx announces data showing effect of AMX0035 on biomarkers in ALS

Amylyx Pharmaceuticals announced the publication of analyses performed on neuroinflammatory biomarkers using plasma samples from participants with amyotrophic lateral sclerosis ALS from the Phase 2 CENTAUR trial. These findings were published in the peer-reviewed medical journal, Journal of Neurology, Neurosurgery and Psychiatry. During the CENTAUR trial, plasma samples were prospectively collected from trial participants for future biomarker analyses. Post hoc analyses were conducted to look at the impact of AMX0035 on biomarkers shown to correlate with ALS disease progression, including chitinase biomarkers such as YKL-40 , chitinase 1 CHIT1 , and the systemic inflammatory biomarker C-reactive protein . The results of these post hoc analyses demonstrated a significant reduction in plasma concentrations of YKL-40 and CRP, but not CHIT1, over 24 weeks, with reductions observed as early as Week 12 in participants from the CENTAUR trial. Of the 135 participants in the modified intent-to-treat population of the CENTAUR trial, 126 had plasma samples available for these analyses. The analyses showed that geometric least squares mean YKL-40 and CRP plasma concentrations were 10% and 17% lower, respectively, at Week 12 and approximately 20% and 30% lower, respectively, at Week 24 in the AMX0035 versus placebo group. YKL-40 and CRP concentrations correlated with ALSFRS-R total score and ALSFRS-R slope. Geometric LS mean CHIT1 plasma levels were not significantly different between treatment groups. Further analyses of neuroinflammatory biomarkers are planned in the ongoing Phase 3 PHOENIX trial to confirm these results.