Positive data reported in phase 2 study of treatment for Parkinson’s, Lewy body dementia

A clinical-stage biopharmaceutical company has announced positive findings from the exploratory SHAPE phase 2 clinical trial to evaluate fosgonimeton in those with Parkinson’s disease dementia and dementia with Lewy bodies.

According to a release issued by Athira Pharma, the investigational, small molecule ATH-1017 is designed to positively modulate the hepatocyte growth factor (HGF) system, which can activate neuroprotective, neurotrophic and anti-inflammatory pathways in the central nervous system.

In SHAPE, all five participants from the modified intent-to-treat population who were given 40 mg fosgonimeton once daily saw improvement in the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), while both individually and collectively demonstrating “statistically significant” improvement (-7.2 points at 26 weeks) compared with placebo, according to the release.

However, the company further stated, the trial’s primary endpoint — a composite score of the change in Event-Related-Potential (ERP) P300 latency and ADASCog13 — was not met compared with placebo.

“These findings support the potential of targeting HGF system positive modulation as a broadly applicable strategy for treating neurodegenerative diseases,” Hans Moebius, MD, PhD, chief medical officer of Athira, said in the release.

Data from the study further showed fosgonimeton was generally well-tolerated, with a favorable safety profile and no treatment-related serious adverse events or deaths recorded.

“Collectively, these preclinical and clinical outcomes support continued development of our HGF system positive modulators in diseases with differing pathologies,” Kevin Church, PhD, chief scientific officer of Athira, said in the release.