Athira Pharma, Inc. engages in the development of small molecules to restore neuronal health and stop neurodegeneration. Its product pipeline includes ATH-1017, ATH-1019/20, and ATH-1018. The company was founded by Leen Kawas, John Wright, Lewis Rumpler, and Joseph Harding in March 2011 and is headquartered in Bothell, WA.
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2011
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- Athira Pharma acquired exclusive global rights to lasofoxifene, a breast cancer treatment currently in a potentially registrational Phase 3 trial with data expected in mid-2027. - The company secured $90 million in private placement financing to support lasofoxifene development through key clinical and regulatory milestones with runway into 2028. - Sermonix Pharmaceuticals will receive a pre-funded warrant for approximately 5.5 million shares and up to $100 million in milestone payments based on commercialization success. - Athira's stock surged 74% following the announcement, reaching a new 52-week high as investors responded positively to the late-stage asset acquisition.
- Athira Pharma acquired exclusive global licensing rights to lasofoxifene, a selective estrogen receptor modulator in Phase 3 development for ESR1-mutant metastatic breast cancer. - The company secured $236 million in total financing, including $90 million upfront and up to $146 million through warrants, to support development through regulatory milestones. - Lasofoxifene demonstrated promising Phase 2 results with 13 months progression-free survival in heavily pretreated patients and targets approximately 40% of breast cancer patients who develop ESR1 mutations. - The ongoing Phase 3 ELAINE-3 trial is more than 50% enrolled with topline data expected in mid-2027, potentially establishing a new standard of care for this genetically defined patient population.
- Alzheon is set to present Phase 3 trial data for ALZ-801 in April 2025, a drug designed to prevent the formation of toxic beta-amyloid plaques in early Alzheimer's patients with the ApoE4 gene. - Anavex Life Sciences has submitted blarcamesine for approval in Europe after completing Phase 2/3 trials, though its efficacy has faced criticism and legal challenges. - Athira Pharma discontinued fosgonimeton development after failing to demonstrate clinical benefit and settled with the DOJ over data manipulation allegations. - Eisai and Biogen's Leqembi may become more accessible with an injectable version under FDA review, potentially allowing for at-home administration.
• Athira Pharma presented Phase 2/3 LIFT-AD trial results of fosgonimeton for Alzheimer's at CTAD, Madrid, from October 29 to November 1, 2024. • The LIFT-AD trial did not meet statistical significance for its primary endpoint, the Global Statistical Test, at 26 weeks compared to placebo. • Subgroup analysis showed cognitive and functional improvements in patients with moderate Alzheimer's and APOE4 carriers treated with fosgonimeton. • ATH-1105, a next-generation small molecule HGF modulator, is being advanced for ALS and Alzheimer's, with Phase 1 trial data expected by year-end 2024.
- The Alzheimer's disease therapeutic pipeline is expanding beyond amyloid and tau targets, with 32 therapeutics in 48 Phase III trials exploring neuroprotection, neurotransmitters, and inflammation. - Recent approvals of anti-amyloid antibodies like Leqembi and Kisunla have shown modest clinical benefits but also carry risks, prompting the development of alternative approaches. - Several Phase III candidates, such as Athira's fosgonimeton, Anavex's ANAVEX 2-73, and Novo Nordisk's semaglutide, target different mechanisms like neurotrophic factors, neuronal homeostasis, and neuroinflammation. - Experts suggest that combination therapies and brain-healthy lifestyles may be essential for effectively managing the heterogeneous nature of Alzheimer's disease.
- Athira Pharma's fosgonimeton did not meet the primary endpoint in the Phase II/III LIFT-AD trial for mild-to-moderate Alzheimer's disease. - The trial failed to show statistically significant improvement in cognition and function compared to placebo after 26 weeks of treatment. - Subgroup analyses showed some improvements in cognition and function in patients with moderate Alzheimer's and APOE4 carriers. - Despite the setback, Athira Pharma believes the data suggest potential benefits of HGF pathway modulation on neuronal health.
