Athira Pharma
Chief Medical Officer
Hans J. Moebius received is MD degree from the University of Heidelberg, followed by a PhD in Experimental Pharmacology on second messenger mechanisms. He continued his research and lecturing tenure at Max-Planck-Institute for Brain Research, Frankfurt/M. Hans is board-certified in neurology and psychiatry after his residencies at the University Clinics Frankfurt/M. For the past 30+ years, his focus was on drug development, starting at Novartis, and later EU and US companies as CMO, working in neuropsychiatric indications and with diverse approaches in neurodegenerative disorders. Six CNS drugs made it to market with his leadership, e.g. memantine and incobotulinumtoxin A. He is co/inventor of Namzaric®, Deraphan®, and several more patents, and co-founder of Exciva, a German biotech start-up. Since 2019, Hans serves as CMO at Athira Pharma, Seattle, USA.

Presenter of 1 Presentation

STUDY DESIGN AND PARTICIPANT CHARACTERISTICS OF A PHASE 2 TRIAL OF ATH-1017, A NOVEL TREATMENT FOR MILD-TO-MODERATE ALZHEIMER’S DISEASE

Session Type
SYMPOSIUM
Date
Sun, 20.03.2022
Session Time
09:05 AM - 11:05 AM
Room
ONSITE: 113
Lecture Time
09:50 AM - 10:05 AM

Abstract

Aims

To describe the ongoing ACT-AD study, a 26-week, randomized, double-blind, placebo-controlled study in mild-to-moderate Alzheimer’s disease (AD) with ATH-1017. ATH-1017 is a small-molecule enhancer of HGF/MET, a neurotrophic pathway impaired in AD. Neuronal MET expression is decreased in the cortex and hippocampus, which may contribute to synaptic loss, neurodegeneration, and functional decline. Enhancement of HGF/MET activity has the potential to restore neuronal connections and improve cognition. The ACT-AD study seeks to replicate and extend the previously shown improvement of ERP P300 latency, the primary endpoint and a non-invasive neurophysiological biomarker of cognitive performance.

Methods

ACT-AD has a target enrollment of 75 patients (aged 55-85, CDR 1 and 2, MMSE 14-24) in the US and Australia. Subjects are randomized 1:1:1 to placebo, 40 mg, or 70 mg dose of ATH-1017 with a once daily subcutaneous injection. In addition to ERP P300 latency and safety, ADAS-Cog11, ADCS-CGIC, ADCS-ADL23, COWAT, NPI, and other measures are protocoled. Summary statistics for demographic and baseline characteristics for the overall patient population are presented.

Results

The first 67 enrolled patients have a mean(SD) age of 71.9 (7.2), of whom 54% are female and 46% male, and 91% are white. Mean (SD) baseline MMSE score is 19.2 (3.0), with a minimum of 14 and a maximum of 24. ApoE4 carriers make up 56% of the population, with 44% as non-carriers. Data will be updated once enrollment is complete.

Conclusions

Enrolled subjects represent an appropriate population to evaluate the treatment effects of ATH-1017 on ERP P300.

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