ALBRIOZA Commercial Launch slide image

ALBRIOZA Commercial Launch

Upcoming Pivotal Phase 3 Study in Progressive Supranuclear Palsy (PSP) PSP is Associated with Tau Protein Rare neurological disorder that affects body movements, walking and balance, and eye movement. Pathology characterized by widespread neurodegeneration associated with tau protein deposition in subcortical regions of the brain. AMX0035 Demonstrates Potent Impact on Tau4,5 Data from Phase 2 PEGASUS study in Alzheimer's disease demonstrated that AMX0035 lowered total tau by 64.9 pg/mL and lowered phosphorylated tau by 14.6 pg/mL at week 24. Select CSF Biomarkers Change from Baseline to Week 24 LS Mean Week 24 (95% CI) p-value (nominal) Linear mixed effect AMX0035 Placebo Difference between AMX0035 and Placebo Estimated prevalence of * 5-7 in 100,000 worldwide¹ model estimation PSP is typically fatal within 5 to 8 years2,3 Total Tau (pg/mL) -64.9 8.8 -73.7 (-106.8, -40.7) <0.0001 Phosphorylated Tau (pTau181) (pg/mL) -14.6 -0.3 -14.4 (-21.5, -7.2) 0.0002 1. Shoeibi A., Olfati N., Litvan I. Frontrunner in translation: Progressive supranuclear palsy. Front. Neurol. 2019;10:1125. doi: 10.3389/fneur.2019.01125. Swallow D.M., Zheng C.S., Counsell C.E. Systematic review of prevalence studies of progressive supranuclear palsy and corticobasal syndrome. Mov. Disord. Clin. Pract. 2022;9:604-613. doi: 10.1002/mdc3.13489. 2. Williams DR, Lees AJ. Progressive supranuclear palsy: clinicopathological concepts and diagnostic challenges. Lancet Neurol 2009;8(3):270-279. 3. Guasp M., Molina-Porcel L., Painous C., Caballol N., Camara A., Perez-Soriano A., Sánchez-Gómez A., Garrido A., Muñoz E., Marti M.J. Association of PSP phenotypes with survival: A brain-bank study. Parkinsonism Relat. Disord. 2021;84:77-81. doi: 10.1016/j.parkreldis.2021.01.015. 4. Analysis conducted with biomarker core lab of the Mass General Institute for Neurodegenerative Disease (MIND) on CSF samples. Data from Phase 2 PEGASUS trial of AMX0035 for the treatment of Alzheimer's disease. Arnold et al. CTAD 2022. 5. Marie K. Bondulich, Tong Guo, Christopher Meehan, John Manion, Teresa Rodriguez Martin, Jacqueline C. Mitchell, Tibor Hortobagyi, Natalia Yankova, Virginie Stygelbout, Jean-Pierre Brion, Wendy Noble, Diane P. Hanger, Tauopathy induced by low level expression of a human brain-derived tau fragment in mice is rescued by phenylbutyrate, Brain, Volume 139, Issue 8, August 2016, Pages 2290-2306, https://doi.org/10.1093/brain/aww137 AMYLYX 30
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