Athira Pharma announces results from exploratory Phase 2 trial of fosgonimeton

Athira Pharma announced findings from the exploratory SHAPE Phase 2 clinical trial to evaluate fosgonimeton in patients with Parkinson’s disease dementia and dementia with Lewy Bodies. Fosgonimeton is a potentially first-in-class, investigational, small molecule designed to positively modulate the hepatocyte growth factor system, which can activate neuroprotective, neurotrophic and anti-inflammatory pathways in the central nervous system. The primary endpoint of SHAPE, a composite score of the change in Event-Related-Potential P300 latency and cognitive assessment, was not met compared with placebo. However, all five patients in the modified intent to treat population treated with fosgonimeton 40 mg once daily saw improvement in ADAS-Cog13 individually and collectively showed a statistically significant improvement compared with placebo. In addition, directional improvements in other cognitive, functional and biomarker measurements were observed in the fosgonimeton 40 mg treatment group. Results for patients in the 70 mg treatment group were inconsistent, potentially due, in part, to a higher dropout rate from baseline enrollment than both the 40 mg and placebo groups. Fosgonimeton was generally well tolerated, with a favorable safety profile. There were no treatment-related serious adverse events or deaths observed in the study. The most common adverse event in the treatment groups was injection site reactions.