Athira Pharma has dosed the first subject in the Phase I clinical trial of its treatment candidate, ATH-1020, to potentially treat neuropsychiatric conditions.
An orally available, brain-penetrant small molecule, ATH-1020 is created to boost HGF/MET system.
The first-in-human placebo-controlled, randomised, double-blind, two-part trial will assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of ATH-1020 in healthy subjects.
It will enrol nearly 68 subjects aged 18 to 85 years.
Part A or the single ascending dose (SAD) portion will assess up to four dose levels of ATH 1020.
In Part B or the multiple ascending dose (MAD) portion, up to three dose levels of ATH-1020 will be evaluated.
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The primary endpoint of the trial is to analyse the safety and tolerability of the molecule.
According to the preclinical findings, ATH-1020 could lower depression-like behaviours and rescue mismatch negativity response.
These are translatable measures of event-linked potential that demonstrates steady and strong deficits in rodent models and patients with schizophrenia.
Athira Pharma president and CEO Mark Litton said: “Our novel approach targeting HGF/MET and ATH-1020’s unique pharmacology and mechanism of action, may be particularly well suited for potential treatment of neuropsychiatric indications, as evidenced by the compelling preclinical data we have recently presented.
“We anticipate that the safety, tolerability and pharmacokinetic data from this Phase I study will help inform our further assessment of the potential of ATH-1020 in future clinical indications.”
In October last year, the company concluded subject enrolment in a placebo-controlled, randomised, Phase II ACT-AD trial of its small molecule, ATH-1017, in mild-to-moderate Alzheimer’s disease patients.
It enrolled 77 patients at 14 trial centres in the US and Australia.