Athira Pharma has reported data from the Phase II SHAPE clinical trial of fosgonimeton (ATH-1017) to treat Parkinson’s disease dementia, and dementia with Lewy Bodies (DLB).

An investigational small molecule, fosgonimeton can positively modulate the hepatocyte growth factor (HGF) system to stimulate the central nervous system’s neurotrophic, anti-inflammatory, and neuroprotective pathways.

The double-blind, randomised, parallel-group, placebo-controlled trial is designed to evaluate ATH-1017. 

In the trial, patients were randomised into a 1:1:1 ratio into two dose arms and a placebo arm to receive either a subcutaneous dose of ATH-1017 or a placebo once a day for 26 weeks. 

A combined score of the variation in Event-Related-Potential (ERP) P300 latency and cognitive assessment (ADAS-Cog13) was the trial’s primary endpoint.

ERP P300 latency measures the working memory processing speed. 

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By GlobalData

The trial of ATH-1017 failed to meet the primary goals when compared to the placebo. 

Despite this, all five subjects in the modified intent-to-treat (mITT) population who received fosgonimeton demonstrated individual improvement in ADAS-Cog13. 

The patients collectively showed a statistically significant improvement versus the placebo. 

In addition, directional improvements in other functional, cognitive, and biomarker measurements were observed in the fosgonimeton 40mg treatment arm. 

Results for the 70mg treatment group were found to be inconsistent.

In the trial, fosgonimeton was demonstrated to be well tolerated, with a good safety profile. 

No treatment-linked serious adverse events or mortality were reported in the trial, with injection site reactions observed to be the most frequent adverse event. 

Athira Pharma president and CEO Mark Litton said: “These encouraging findings from the SHAPE trial further bolster our confidence in the ongoing Phase II/III LIFT-AD trial of fosgonimeton as a potential treatment for Alzheimer’s disease and support our May 2023 amendment to the LIFT-AD protocol to pursue the 40mg dose versus placebo and discontinue the 70mg dose.

“More broadly, we are encouraged by the clinical and preclinical evidence that support the potential therapeutic effects of HGF system positive modulation across a wide range of neurodegenerative diseases.”