On December 2, Alzheon Chief Medical Officer, Susan Abushakra, presented data from the 12-month interim analysis of their Phase 2 biomarker study of ALZ-801, demonstrating a favourable safety profile and a significant reduction in the Alzheimer’s disease biomarker, pTau-181. ALZ-801 (valitramiprosate) is an oral drug that is reported to prevent the aggregation of amyloid proteins into toxic oligomers, which accumulate in the brains of people with Alzheimer’s disease (AD). In their Phase 2 biomarker study, Alzheon enrolled 84 participants with early AD, who have two high-risk versions of the APOE4 genetic risk factor (APOE4/4, or APOE3/4). In total, 75 participants (mean age 69 years, 52% female) completed 52 weeks on the drug, which they received via oral administration ALZ-801 twice daily. In her presentation, Dr. Abushakra explained that participants who received ALZ-801 had a significant, 41% reduction in the levels of the blood biomarker, pTau-181.
This biomarker signals an increase of tau tangles in the brain, which in turn is linked to Alzheimer’s disease development. In addition, hippocampal volumes were preserved in these participants, indicating a reduction in brain atrophy for participants taking ALZ-801. The company also announced that the Phase 3 trial of ALZ-801, APOLLOE4, has completed enrolment of participants with the high-risk APOE4/4 genotype who have early AD, at 93 trial sites across the US, Canada, Iceland, France, Spain Czech Republic, and other countries in Europe. Participants will be randomised to receive oral ALZ-801 or placebo for a period of 78 weeks, with trial endpoints that include cognitive and functional measures (ADAS-Cog13, CDR-SB) as well as biomarker analyses. Read the Alzheon press release, here:
