Athira Pharma CEO Leen Kawas

Seattle-based biotech company Athira Pharma announced a three-year grant totaling $15 million from the National Institute on Aging to support an upcoming clinical trial of a treatment that seeks to stop the deterioration of neurons and restore healthy brain activity in people with mild to moderate cases of Alzheimer’s disease.

The grant from the NIA, part of the National Institutes of Health, “underscores the significant impact of these diseases and the need for effective prevention and treatment options,” said Athira CEO Leen Kawas in a statement. 

Athira, which has not yet generated revenue, raised net proceeds of $186 million in its initial public offering in September, and had $260 million in cash and equivalents as of Sept. 30, according to its quarterly regulatory filing. The company posted a net loss of $8.5 million in the September quarter, with $5.1 million of its $5.8 million in research and development expenses going toward its lead therapeutic candidate, ATH-1017.

Athira’s development pipeline for therapies produced from its ATH drug discovery platform as of August 2020. (Via Athira S-1 Filing)

Administered through a small injection under the skin, ATH-1017 uses small molecules to cross the blood-brain barrier to activate a naturally occurring regenerative system known as the hepatocyte growth factor/MET, or HGF/MET.

The NIH/NIA funding will support an upcoming Phase 2 clinical trial of ATH-1017 that will use an electroencephalogram (EEG) test and a cognitive test to help assess its effectiveness. Initial dosing is slated to begin in this trial by the end of the year. Separately, patient dosing began in October for a Phase 2/3 clinical trial that will include 300 Alzheimer’s patents in the U.S. and Australia. The company expects initial results from this trial by the end of 2022.

Listing its competitors in its IPO filing, Athira cited other companies using small molecules to target the HGF/MET system for different diseases and disorders: Angion for kidney injury; and Mitsubishi Tanabe and AnGes for critical limb ischemia. However, Athira said it was “not aware of any direct competitors currently targeting the HGF/MET system for neurological conditions.”

The company acknowledged monoclonal antibody therapies for Alzheimer’s under development by biotech giants Biogen, Eli Lilly and Roche, but said it considered them complementary rather than competitive to its treatments.

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