On 8 January, Athira Pharma, a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, provided a clinical pipeline outlook and business update for 2024. The company announced completion of enrollment in its Phase II/III LIFT-AD clinical trial of fosgonimeton as a potential treatment for mild-to-moderate Alzheimer’s disease (AD). This trial enrolled 315 participants who received 40 mg fosgonimeton or a placebo for 26 weeks once daily by subcutaneous injections.
The primary endpoint is the Global Statistical Test (GST), a composite of the co-key secondary endpoints ADAS-Cog11 and ADCS-ADL23. Key secondary and exploratory endpoints include changes in plasma biomarkers of neurodegeneration, protein pathology, and neuroinflammation. Topline data from LIFT-AD are expected in the second half of 2024. Eligible participants who complete the LIFT-AD or ACT-AD (exploratory Phase II clinical trial) trials can participate in the open label extension trial (OLEX) and are able to receive up to 30 months of open-label treatment. So far, more than 85% of those who completed either study have been enrolled in OLEX, with 60 participants continuing treatment beyond 18 months.
In addition, the company recently reported findings from the exploratory SHAPE Phase II clinical trial, which investigated the use of fosgonimeton in people with Parkinson’s disease dementia and dementia with Lewy Bodies. Fosgonimeton was generally well tolerated, with a favorable safety profile. The results showed positive effects on several cognitive measures in people who received fosgonimeton 40 mg compared to those receiving placebo over the 6-month double-blind treatment period. However, the primary endpoint, a composite score of the change in Event-Related-Potential (ERP) P300 latency and cognitive assessment (ADAS-Cog13), was not met compared with placebo.
