Athira Pharma Announces Topline Results from Phase 2/3 LIFT-AD Clinical Trial of ...
Athira Pharma announced that its Phase 2/3 LIFT-AD trial of fosgonimeton did not meet primary or key secondary endpoints for Alzheimer's disease, but showed potential in specific subgroups and biomarker improvements.
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LIFT-AD trial of fosgonimeton in mild-to-moderate Alzheimer's disease did not meet primary endpoint of GST and key secondary endpoints of cognition and function. However, in subgroups with moderate AD or APOE4 carriers, fosgonimeton showed numerically greater treatment effects. Biomarkers of AD pathology showed changes consistent with HGF modulation neuroprotection.
Athira Pharma's Phase II/III LIFT-AD trial of fosgonimeton for Alzheimer's disease failed to meet primary and secondary endpoints, with the therapy showing no significant improvement over placebo. The company cited lack of decline in the placebo group and short study duration as possible reasons. Despite the setback, Athira remains optimistic about the potential of HGF pathway modulation for neuronal health improvement and disease mitigation, encouraged by biomarker and subgroup data.
Athira Pharma's experimental Alzheimer's drug fosgonimeton failed to show clinical benefit in a Phase 2/3 trial, despite targeting the HGF/MET pathway to protect brain cells. The placebo group did not experience cognitive decline, complicating the drug's efficacy assessment. The company did not announce further trials.
Fosgonimeton, an investigational medication from Athira Pharma, did not significantly improve cognitive and daily functioning in a Phase 2/3 trial for mild to moderate Alzheimer’s disease, despite being safe and well-tolerated. The trial’s primary endpoint, the Global Statistical Test (GST), showed a small difference favoring fosgonimeton over placebo, but not statistically significant. Fosgonimeton did show some numerical superiority in pre-specified groups, such as those with more advanced Alzheimer’s or the APOE4 gene variant. The treatment also resulted in a significant reduction in blood tau levels and other Alzheimer’s biomarkers, though not significantly. Fosgonimeton was generally well-tolerated, with more treatment-emergent side effects, mostly injection site reactions.
Athira Pharma's lead candidate, fosgonimeton, failed Phase II/III LIFT-AD trial for Alzheimer's, causing a 81% stock drop. Despite missing primary and secondary endpoints, Athira remains committed to fosgonimeton's development, citing potential benefits in specific subgroups. Full data will be presented at the CTAD Conference in Madrid.
The LIFT-AD trial showed fosgonimeton failed to meet its primary endpoint in mild-to-moderate Alzheimer's disease but had a numerically greater effect in APOE carriers. Fosgonimeton was generally well-tolerated with a favorable safety profile. Full data will be presented at the CTAD conference in Madrid.
Athira Pharma announced that its Phase 2/3 LIFT-AD trial of fosgonimeton did not meet primary or key secondary endpoints for Alzheimer's disease, but showed potential in specific subgroups and biomarker improvements.