Athira Pharma Extends Study Duration for Alzheimer’s Study

Litton Athira_Courtesy of company

Athira CEO Mark Litton/Courtesy of Athira Pharma

Athira Pharma announced that the duration of its open-label study of fosgonimeton for the treatment of mild-to-moderate Alzheimer’s Disease (AD) has been increased from six months to eighteen months.

The decision to extend the length of the study is in alignment with the independent Data and Safety Monitoring Board’s review of the most recent available data. Now, participants in the Phase III Lift-AD and Phase II Act-AD trials may receive up to 18 months of treatment.

Fosgonimeton is a small molecule that works by enhancing the activity of hepatocyte growth factor (HGF) and its receptor, MET. The HGF-MET pathway is involved in neuronal growth and survival and is thought to be impaired in those with AD, contributing to neurodegeneration. In healthy patients, HGF is a key factor in preventing neuronal death and promoting survival by providing immunomodulatory mechanisms that decrease inflammation.

The primary endpoint for the study is the Global Statistical Test, which combines biomarkers and clinical outcomes in AD. Secondary endpoints include measures of cognition, including executive function and working memory, as well as behavior.

Apart from the Alzheimer's study, Athira has recently made headlines, announcing that the investigation of its officers and directors is still ongoing. The investigation stems from allegations in October 2021 that Athira’s CEO at the time, Leen Kawas, had produced and published altered research when she was a graduate student. Athira’s board moved to replace Kawas with Mark Litton.

However, Athira investor Richard Kayne called for Litton to be replaced due to a lack of clinical or scientific experience. Athira's board disagreed with Kayne’s assertion.

After the revelation that Kawas had produced fraudulent research, Charles C. Foti, former Attorney General of Louisian and partner at the law firm of Kahn Swick & Foti, opened an investigation. The investigation's goal is to determine whether Athira’s officers and/or directors breached their fiduciary duties to the company’s shareholders or otherwise violated state or federal laws. 

In other news, Athira filed an investor presentation in April 2022, which included information about how the company is successfully executing its strategic priorities and is well-positioned to move into the second quarter of 2022. Among its successes include clinical trials investigating fosgonimeton in patients with AD, Parkinson’s Disease and dementia with Lewy bodies. The company also doubled down on insisting that its management team is in good hands with Litton and that it has the right board to oversee the company.

Athira is also underway with a Phase I clinical trial of ATH-1020 evaluating its safety, tolerability and pharmacokinetics. ATH-1020 is intended to treat neuropsychiatric conditions, with preclinical data showing that the drug is able to mitigate depression-like behaviors and normalized sensory processing deficits in schizophrenia.

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