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Athira Says Phase II Alzheimer’s Miss Will Inform Ongoing Phase III Study

 
• By Joseph Haas

Athira hoped a small Phase II study would show a benefit on working memory processing speed, but it missed its primary and all secondary endpoints, reducing confidence in the Phase III program.

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Athira faces a setback for its mechanism against Alzheimer's disease

Add Athira Pharma, Inc. and its HGC/MET activator fosgonimeton (ATH-1017) to the list of struggling, if not yet failed, mechanisms of action for Alzheimer’s disease as the biotech reported an unsuccessful Phase II study on 22 June. Fosgonimeton also missed secondary endpoints in the 77-patient clinical trial, which attempted to show a memory-processing benefit in mild-to-moderate patients.

Some observers had viewed the US Food and Drug Administration approval of Biogen, Inc./Eisai Co., Ltd.’s amyloid-clearing antibody Aduhelm (aducanumab) in 2021 as a hopeful sign for companies studying a variety of mechanisms in Alzheimer’s disease, but the field has repeatedly seen clinical trial misses while Aduhelm’s clinical benefit has been questioned constantly and uptake of the drug has been spotty

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