Athira Pharma, makers of experimental Alzheimer’s drug fosgonimeton, paid up $4 million to settle a federal case following allegations that the company manipulated scientific data to get federal research grants.
On January 6th, 2025 the U.S. Department of Justice announced that Alzheimer’s drugmaker Athira Pharma agreed to pay more than $4 million to settle allegations that it knowingly used studies containing falsified data to secure grant funding from the National Institutes of Health. The settlement comes a few months after the company’s experimental Alzheimer’s drug fosgonimeton failed to show a clinical benefit in its latest clinical trial.
The small molecule drug, administered via injection under the skin, is designed to switch on a cellular signaling pathway called HGF/MET that has been shown to help support healthy brain function and protect brain cells from inflammation and neurodegenerative disease in mouse models and cells.
However, the company’s CEO stepped down in 2021 due to a data manipulation scandal related to her research on identifying this pathway as a potential target for treating the disease.
The former CEO’s academic work was cited in grants submitted by Athira Pharma between January 1, 2016, and June 20, 2021. However, at the time the company submitted the grants they did not disclose that these papers were alleged to obtain falsified and manipulated scientific images.
Athira’s Alzheimer’s Drug Fails in Later-stage Clinical Trial
Late-stage trial failure
Athira’s experimental Alzheimer’s drug fosgonimeton failed in a recent 26-week, Phase 2/3 trial clinical trial. The trial’s 312 participants with mild to moderate Alzheimer’s were split randomly into two groups: One half received the drug, while the other half received a placebo. The results indicate that the participants who took the drug did not show slower cognitive decline than the placebo group.
“These are not the results we hoped for,” Dr. Javier San Martin, chief medical officer of Athira, said in a press release at the time. The participants in the placebo group didn’t experience cognitive decline over the 26 weeks, as would be expected in Alzheimer’s disease.
The company speculated that this might have made it harder to show that the drug works to slow cognitive decline. Athira spokespeople also communicated that they believed that the study might have been too short to see an effective change.
What happens next
As a result of the failed trial and the data falsification case, Athira’s stock price dropped which may result in the company getting delisted from the Nasdaq stock exchange. It has also faced financial difficulties, letting go of 70 percent of its staff last September. The company has not yet announced whether they will run another drug trial, but there are many other drugs making their way through clinical trials to treat Alzheimer’s.
