On 21 May, Annovis Bio, a clinical-stage drug platform company developing novel treatments for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson’s disease (PD), announced results from its Phase II clinical trial investigating its lead compound ANVS401. ANVS401 is a small orally administrated brain penetrant inhibitor of neurotoxic proteins. This ongoing study is a multicenter, randomised, double-blind and placebo-controlled trial evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ANVS401 in people with early AD and early PD. The company is expecting to enrol 68 research participants at 15 sites across the US in two parts of the study.
In the first part of the study, 14 participants with AD and 14 participants with PD received either placebo or ANVS401 (80mg) daily for 25 days. Their biomarkers are being measured. Results showed that participants with AD receiving ANVS401 showed a statistically significant improvement in cognition (30%), as measured by the Alzheimer’s Disease Assessment Scale–Cognitive Subscale 11 (ADAS-Cog11). The improvements were also observed in people with PD enrolled in the study. In addition, no adverse events were observed. The second part of the study will investigate multiple doses of ANVS401 in 40 people with PD. The company expects to receive the full study data this year.
