Athira Pharma to Present Overview and Update from ACT-AD Phase 2 Trial of Fosgonimeton (ATH-1017) in Mild-to-Moderate Alzheimer’s Disease at AD/PD™ 2022 Congress
Athira Pharma (NASDAQ: ATHA) announced an update on its fully enrolled ACT-AD Phase 2 clinical trial for fosgonimeton (ATH-1017) in mild-to-moderate Alzheimer's disease. The trial has enrolled 77 subjects across the US and Australia, focusing on cognitive and functional measures. Presentation details include a session at the AD/PD 2022 congress in Barcelona on March 20, 2022. Fosgonimeton aims to restore neuronal health and slow neurodegeneration. The primary endpoint is Event-Related-Potential (ERP) P300 Latency.
- Fully enrolled ACT-AD Phase 2 trial with 77 subjects, indicating strong interest.
- Primary endpoint focus on cognitive function, vital for Alzheimer's treatment.
- Presentation at AD/PD 2022 congress highlighting commitment to research.
- Trial outcomes are uncertain; efficacy of fosgonimeton yet to be established.
- Future development may hinge on preliminary data from Phase 1a/b trials.
BOTHELL, Wash., March 14, 2022 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced that an overview and update of the fully enrolled ACT-AD Phase 2 clinical trial with Athira’s lead development candidate fosgonimeton (ATH-1017) in mild-to-moderate Alzheimer’s disease, will be presented at the International Conference on Alzheimer's & Parkinson Diseases™ 2022, AD/PD™ 2022 hybrid congress, taking place March 15-20, 2022 virtually and in Barcelona.
Presentation Details:
Title: Study Design and Participant Characteristics of a Phase 2 trial of ATH-1017, a Novel Treatment for Mild-to-Moderate Alzheimer’s Disease
Session: Abeta and other targeting therapies in AD (#113)
Presenter: Hans Moebius, M.D., Ph.D., Chief Medical Officer, Athira Pharma, Inc.
Date and Time: Sunday, March 20, 2022, 9:50 a.m. CET
Location: Barcelona, Spain
The presentation slides and an accompanying poster will be available on the Events and Presentations page of the Investors section of Athira’s website at www.athira.com.
About Fosgonimeton (ATH-1017)
Fosgonimeton (ATH-1017) is a small molecule designed to enhance the activity of hepatocyte growth factor (HGF) and its receptor, MET, to impact neurodegeneration and regenerate brain tissue. The function of the HGF/MET receptor system may be impaired in the brain under conditions of neurodegeneration. Athira is currently evaluating fosgonimeton in multiple clinical trials.
About ACT-AD
ACT-AD is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial for fosgonimeton (ATH-1017) in subjects with mild-to-moderate Alzheimer’s disease. The study has completed enrollment with 77 subjects in the United States and Australia. Study participants were randomized across two dose groups and one placebo group on a 1:1:1 basis to receive a subcutaneous injection of fosgonimeton or placebo once daily over a treatment course of 26 weeks. The primary endpoint for ACT-AD is Event-Related-Potential (ERP) P300 Latency, a functional measure of working memory processing speed, and secondary endpoints measuring cognition, function, and behavior. Additional information on the study can be found at: https://clinicaltrials.gov/ct2/show/NCT04491006. The ACT-AD trial is supported by a grant from the National Institute on Aging of the National Institutes of Health under Award Number R01AG06268. The information presented in this press release and at the AD/PD conference is solely the responsibility of Athira and does not necessarily represent the official views of the National Institutes of Health.
About Athira Pharma, Inc.
Athira Pharma Inc., headquartered in the Seattle area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to provide rapid cognitive improvement and alter the course of neurological diseases with its novel mechanism of action. Athira is currently advancing its lead therapeutic candidate, fosgonimeton, a novel small molecule for Alzheimer’s and Parkinson’s disease dementia and Dementia with Lewy bodies. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn and @athirapharma on Twitter and Instagram.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding fosgonimeton as a potential treatment for Alzheimer’s disease, Parkinson’s disease dementia and Dementia with Lewy bodies, and other dementias; Athira’s platform technology and potential therapies; future development plans; clinical and regulatory objectives and the timing thereof; expectations regarding the potential efficacy and commercial potential of Athira’s product candidates; the anticipated reporting of data; and Athira’s ability to advance its product candidates into later stages of development. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,” “continue,” and other similar expressions, among others. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the preliminary data for Athira’s fosgonimeton product candidate from the Phase 1a/b trials will not continue or persist in current or planned clinical trials; cessation or delay of any of the ongoing clinical trials and/or Athira’s development of fosgonimeton and other product candidates may occur; the impact of the COVID-19 pandemic on Athira’s business, research and clinical development plans and timelines, and the regulatory process for Athira product candidates; the outcome of legal proceedings which have been or may in the future be instituted against us and certain of our directors and officers; clinical trials may not demonstrate safety and efficacy of any of Athira’s product candidates; Athira’s assumptions regarding the sufficiency of its cash, cash equivalents and investments to fund its planned operations may be incorrect; while P300 latency is a functional measure that is highly correlated with cognition, Athira may not successfully establish a connection between these P300 latency results and improved cognition; as well as the other risks detailed in Athira’s filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Athira undertakes no obligation to update forward-looking statements. Athira may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the forward-looking statements.
Investor & Media Contact:
Julie Rathbun
Athira Pharma, Inc.
Julie.rathbun@athira.com
206-769-9219
FAQ
What is the goal of the ACT-AD Phase 2 trial for ATHA?
When will the results of the ACT-AD trial be presented?
What is the primary endpoint of the ACT-AD trial for ATHA?
How many subjects are enrolled in the ACT-AD trial for ATHA?
What are the implications of the fosgonimeton (ATH-1017) trial for Alzheimer's?
