Alzheon presents new findings from its Phase II trial for AD


Alzheon, Inc., a clinical-stage biopharmaceutical company focused on developing new medicines for neurodegenerative disorders such as Alzheimer’s disease (AD), reported one-year findings from its Phase II trial assessing the safety and efficacy of daily ALZ-801 treatment for up to two years in people with early AD who have one or two copies of APOE4. Data were presented in an oral presentation at the American Academy of Neurology (AAN) Conference, held April 22-27 in Boston and virtually.

ALZ-801 is an oral small molecule that works to inhibit the formation of amyloid-beta oligomers, or toxic clumps. Interim six-month results indicated that ALZ-801 safely lowered the levels of p-tau 181, a key biomarker of neurodegeneration, and led to significant memory improvements. A total of 75 participants completed a year of treatment, 70% of which were in the mild cognitive impairment stage and 30% of which were in the mild AD stage. One-year findings supported the interim six-month results with significant reductions in p-tau 181 levels, 41% by week 52 with significant reductions seen as early as 13 weeks.

Moreover, significant reductions in the levels of amyloid-beta were observed at the same time point. ALZ-801 was well tolerated. The Phase II trial will finish later this year. Alzheon is also conducting a Phase III trial, APOLLOE4, to confirm the findings of the Phase II trial in people who have early AD with the high-risk APOE4/4 genotype. Alzheon presented baseline characteristics from the ongoing APOLLOE4 phase III trial at AAN. The APOLLOE4 study is expected to finish in mid-2024. The company plans to file for regulatory approval of ALZ-801 in 2024.