Athira Pharma's Alzheimer's Candidate Fails To Improve Cognition And Function In Patients With Mild/Moderate Disease, Stock Sinks

On Wednesday, Athira Pharma, Inc. ATHA stock is trading lower after the company released topline results from its Phase 2/3 LIFT-AD clinical trial of fosgonimeton for mild-to-moderate Alzheimer’s disease (AD).

A -0.08 change in GST (the Global Statistical Test, a combination of results from measures of cognition (ADAS-Cog11) and function (ADCS-ADL23) favoring fosgonimeton that did not reach statistical significance (p=0.70) 

The change in cognition from baseline, for which a decrease from baseline represents an improvement, was -0.39 for the placebo group and -1.09 for the fosgonimeton-treated group, a difference of -0.70 (p=0.35) favoring fosgonimeton.

In the fosgonimeton-treated group, function increased (improved) by 0.65 versus a decline of -0.02 in placebo, although this difference did not meet statistical significance (p=0.61).

In addition, data across protein pathology, inflammation, and neurodegeneration biomarkers showed directional improvements with fosgonimeton treatment.

“These are not the results we hoped for, as the lack of clinical decline in the placebo group, combined with the short duration of the study, may have impacted the trial’s ability to translate the effect of fosgonimeton treatment into meaningful clinical benefit,” said Javier San Martin, Chief Medical Officer of Athira.

In a subgroup of patients with more advanced disease, the analyses showed a greater numerical treatment effect in clinical outcomes in the fosgonimeton treatment group compared to placebo:

• The change in cognition showed the fosgonimeton treatment group (n=61) improved compared to placebo (n=70), with a delta of -1.16 (p=0.39).
• For AD patients who are carriers of the APOE4 gene, the placebo group (n=74) declined in cognition as assessed by ADAS-Cog11 over the 26 weeks, whereas the fosgonimeton treatment group (n=74) remained stable, with a delta of -1.07 (p=0.33)

In post hoc analysis by disease severity, fosgonimeton showed a larger effect size mainly driven by improved cognition at week 26.

• Patients with the highest baseline ADAS-Cog11 (>30) who were treated with fosgonimeton (n=42) compared to placebo (n=52) showed a -2.51 improvement in cognition (p=0.16), for which a lower number represents an improvement.
• A small subset of patients with moderate dementia who were treated with fosgonimeton (n=20) compared to placebo (n=19) showed a -3.74 improvement in cognition (p=0.21).

Price Action: ATHA stock was down 72.8% at $0.77 during the premarket session at the time of this writing on Wednesday.

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