On 8 February, Alzheon, Inc., a clinical-stage biopharmaceutical company focused on developing new medicines for neurodegenerative disorders such as Alzheimer’s disease (AD), announced findings from its Phase II study evaluating biomarker effects of ALZ-801 (Valiltramiprosate) in early AD. The ongoing Phase II study enrolled 84 people with early AD, who carried one or two copies of the ε4 allele of the apolipoprotein E (APOE4) gene. All participants received an oral tablet of ALZ-801 twice daily. The objectives of this study include determining the efficacy and safety/tolerability of ALZ-801. The company reported interim analysis from a total of 80 participants (mean age 69 years) who completed the week 26 visit.
Results showed a clinically relevant and statistically significant plasma biomarker reduction (29% reduction in plasma P-tau181 at 26 weeks and 18% reduction at 13 weeks) in participants who received ALZ-801. In addition to the biomarkers outcomes, the trial included a standard learning and memory test, Rey Auditory Verbal Learning Test (RAVLT), as a secondary outcome. Significant improvements on memory tests were observed for both immediate and delayed recall in participants who received AL-801. In addition, the safety profile was favourable and consistent with prior data. In the overall 84 participants, the most common adverse event was mild nausea. Alzheon is currently conducting a Phase III clinical trial evaluating the efficacy and safety of ALZ-801 in people with early AD carrying two copies of the APOE4 gene. Approximately 300 participants from US, Canada and Europe will receive either placebo or ALZ-801 twice daily for 78 weeks.