On 10 November, Athira Pharma, a clinical-stage biopharmaceutical company aiming to restore neuronal health in neurodegenerative diseases reported financial results and updates on its two clinical trials evaluating the safety and efficacy of ATH-1017 in people with mild to moderate Alzheimer’s disease (AD). ATH-1017 is an once-daily investigational drug designed to enhance the activity of hepatocyte growth factor (HGF) and its receptor, MET, to impact neurodegeneration and regenerate brain tissue. In both trials — the larger LIFT-AD and ACT-AD — participants are randomly assigned to receive either ATH-1017 at low-dose (40 mg/day), ATH-1017 at high-dose (70 mg/day), or to a placebo for 26 weeks.
The ACT-AD Phase II trial has enrolled 77 participants across 14 sites in the US and Australia. Enrolment has been completed with top-line data expected in the first half of 2022. Its primary aim is to access event-related potential (ERP), a functional measure of working memory processing speed and executive function. Secondary goals include improvements in cognition, function and behaviour. The recruitment of the LIFT-AD Phase II/III study is ongoing in US with top-line data expected by the end of 2022. Participants who complete either the ACT-AD or LIFT-AD trials are eligible to enrol in an open-label extension trial and receive ATH-1017 at the high dose for an additional 26 weeks. In addition, the company expects to initiate a Phase II trial SHAPE for people with Parkinson’s disease dementia or dementia with Lewy bodies by the end of 2021.
