Athira Pharma calls for a fresh approach to treating Alzheimer’s disease

The clinical-stage biopharma Athira Pharma (Nasdaq:ATHA) has published a review paper stressing the need for new treatments for Alzheimer’s disease.

The paper also states that one of its small molecule drugs, fosgonimeton, holds potential for treating Alzheimer’s.

The Journal of Alzheimer’s Disease published the paper titled “The Case for a Novel Therapeutic Approach to Dementia: Small Molecule Hepatocyte Growth Factor (HGF/MET) Positive Modulators.”

ATHA shares were down 1.24% to $3.99 in pre-market trading.

Moving beyond ACT-AD

In June 2022, Athira Pharma revealed disappointing results from the Phase 2 ACT-AD trial focused on Alzheimer’s disease. The study did not show a statistically significant change in ERP P300 latency (a measure of cognitive function) for the modified intent-to-treat population. Fosgonimeton recipients were divided into 40 mg and 70 mg dose groups. Investigators performed a pooled analysi…

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Athira Pharma’s Phase 2/3 LIFT-AD study wins independent endorsement 

The neurodegeneration-focused biopharma Athira Pharma (Nasdaq:ATHA) will continue its Phase 2/3 LIFT-AD study of fosgonimeton (ATH-1017) in patients with mild-to-moderate Alzheimer’s disease.

The company recently announced an unblinded interim efficacy and futility analysis of LIFT-AD. In addition, an independent data monitoring committee recommended continuing the study of fosgonimeton (ATH-1017) in patients with mild-to-moderate Alzheimer’s disease (AD).

In many ways, the past year has not been kind to Seattle-based Athira. Last October, the company announced that its former CEO Lee Kawas and cofounder would resign in the wake of research misconduct allegations. (Kawas has since established an investment firm known as Propel Bio Partners.) In June 2022, Athira announced disappointing results from the Phase 2 ACT-AD trial involving (ATH-101) in Alzheimer’s disease.

Athira’s share price fell from $34.25 on December 31, 2020 to under $3 per share in…

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Athira Pharma stock tanks after announcing results from Phase 2 Alzheimer’s study

The neurodegeneration-focused biopharma Athira Pharma (Nasdaq:ATHA) has seen its stock drop more than 90% since December 31, 2020. Today alone, the company’s share price was down 66.73%, falling to $2.81, in mid-day trading after the company announced disappointing results from the Phase 2 ACT-AD study focused on fosgonimeton in Alzheimer’s disease.

The company announced that the study failed to meet its primary endpoint, which involved a statistically significant change in event-related potential (ERP) P300 latency.

P300 is a measure of decision-making detected using electroencephalography (EEG).

Athira did note the suggestion of a positive effect in a pre-specified subgroup analysis in ERP P300 latency and Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at week 26 relative to placebo.

“Following compelling ERP P300 latency biomarker data from a small Phase 1b trial over eight days in Alzheimer’s…

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​​Athira Pharma to continue open-label Alzheimer’s extension studies

The biopharma Athira Pharma (Nasdaq: ATHA) has lengthened the current open-label extension (OLEX) study for its Phase 3 LIFT-AD and Phase 2 ACT-AD trials of fosgonimeton (ATH-1017, NDX-1017), hepatocyte growth factor receptor agonist, focused on mild-to-moderate Alzheimer’s disease.

The Bothell, Washington–based company made the decision based on feedback from its independent data and safety monitoring board.

ATHA shares fell about 3% to $8.89 in early afternoon trading.

Last October, the company’s former CEO, Leen Kawas, stepped down amidst research misconduct allegations, and Athira’s then-chief operating officer, Mark Litton, assumed the mantle of CEO.

In June 2021, the company announced they had put Kawas on leave. After the announcement, its stock dipped 39%.

In the recent news announcement, Athira said that participants in the LIFT-AD or ACT-AD studies could elect to join the open-label extension that provides up to …

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Athira Pharma shares update on its ACT-AD and LIFT-AD studies of Alzheimer’s candidate ATH-1017

Athira Pharma (NSDQ:ATHA) announced that its lead development candidate, ATH-1017, had balanced baseline characteristics to date in two ongoing late-stage Alzheimer’s studies.

Presenting the data at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference in Boston, the company’s chief medical officer Dr. Hans Moebius said that the baseline characteristics are consistent between the ACT-AD and LIFT-AD studies.

Athira expects topline data from the ACT-AD to be available in the first half of 2022.

ACT-AD is a six-month double-blind Phase 2 trial while LIFT-AD is a six-month double-blind Phase 2/3 study.

ATH-1017 is a subcutaneously delivered small molecule drug that can cross the blood-brain barrier. The drug is designed to improve the activity of the hepatocyte growth factor (HGF) and its receptor, MET. The levels of both HGF and MET tend to be reduced in Alzheimer’s patients.

The company’s Aβ- and tau-…

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Athira Pharma CEO steps down in the wake of research misconduct allegations

Athira Pharma (NSDQ:ATHA) saw its stock jump 9.35% in mid-day trading after the company announced that its embattled CEO Leen Kawas was resigning.

Kawas will also give up her seat on the Bothell, Washington–based company’s board.

Facing allegations that she had doctored a series of images in research papers, Leen Kawas was placed on leave in June.

Several papers she co-authored at the Journal of Pharmacology and Experimental Therapeutics received expressions of concern regarding the possibility of manipulated images.

Mark J. Litton

An internal investigation recently concluded that Kawas had doctored images in several research papers she authored or co-authored while at Washington State University. Kawas received a Ph.D. from the university in molecular pharmacology in 2011.

Mark Litton will assume the CEO mantle of Athira. Litton was the company’s former chief operating officer an…

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Athira Pharma faces shareholder rights investigations

A growing number of law firms are investigating claims of securities fraud associated with Athira Pharma (NSDQ:ATHA), a clinical-stage biopharma focused on small molecules targeting neurodegeneration. Its lead therapeutic candidate, ATH-1017, targets dementia associated with Alzheimer’s and Parkinson’s.

Law firms investigating potential securities fraud claims involving the company include the following:

Ademi (Milwaukee). Block & Leviton (Boston). Johnson Fistel (San Diego). Portnoy (Los Angeles). Wolf Popper (New York City).

The Bothell, Wash.–based company’s stock fell 39% on June 18 after announcing it was putting Leen Kawas, the firm’s CEO, on temporary leave.

Its share price had stabilized in mid-day trading, edging up 1% to $11.27. E

arlier this month, Jefferies predicted thath Athira shares would rise as much as 50% after FDA decided to approve the Alzheimer’s drug aducanumab from Biogen (NSDQ:BIIB).

An Athira Pharma spo…

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Athira Pharma’s stock falls 39% after placing its CEO on leave

The Bothell, Wash.–based clinical-stage biopharma Athira Pharma (NSDQ:ATHA) is in a tailspin after the company’s board put Leen Kawas, the firm’s CEO, on temporary leave.

The company’s stock closed the day at an all-time low of $11.15. The stock was valued as high as $34.25 on Dec. 31, 2020.

Washington State University has launched an independent review of Kawas’s doctoral research in molecular pharmacology and toxicology, which she completed a decade ago.

The university is investigating reports that Kawas authored several papers with altered images.

Get the full story from our sister site, Drug Discovery & Development.

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