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Athira Pharma, Inc. (NASDAQ:ATHA), a late-stage clinical-stage biopharmaceutical company focused on the development of small molecules to restore neuronal health and slow neurodegeneration, announced today that following an interim analysis without blinding to efficacy and futility, an independent data monitoring board recommended continuation of the LIFT-AD study of fosgonimeton (ATH-1017) in patients with Alzheimer’s disease (AD) mild to moderate. The committee also determined that with the additional enrollment of less than 150 patients for a total enrollment of less than 300 patients without disease-modifying therapy (acetylcholinesterase inhibitors), the study will be well-powered for the primary endpoint given the magnitude of the preliminary effect observed. The primary endpoint of LIFT-AD is the Global Statistical Test, an unweighted composite score comprising measures of cognition (Alzheimer’s Disease Assessment Scale-Cognitive Subscale [ADAS-Cog11]) and function (Alzheimer’s Disease Cooperative Study-Activities of Daily Living [ADCS-ADL23]).
Results from the completed ACT-AD Phase 2 exploratory study showed a favorable safety profile and suggested positive effects on measures of cognition (ADAS-Cog11), function (ADCS-ADL23) and neurodegeneration (plasma neurofilament light chain or NfL) in patients taking fosgonimeton without disease-modifying therapy. Guided by these results, the Company proactively modified LIFT-AD to focus on patients not receiving disease-modifying therapy. The unblinded interim analysis was then conducted on approximately 100 patients not receiving disease-modifying therapy to support the findings of ACT-AD and ensure that LIFT-AD is potent enough to determine the effect of fosgonimeton on clinically significant and commercially relevant parameters.
“The results of the data monitoring board’s clear analysis give us confidence in a potentially positive result for LIFT-AD, as rigorous endpoints were applied based on validated, clinically meaningful cognitive and functional outcomes. “said Hans Moebius, MD, Ph.D., chief medical officer of Athira. “This analysis supports the potential clinical benefits of fosgonimeton treatment and underscores the rationale for continued development of this promising new therapy.”
“We are pleased with the results of this independent review, as we believe they mitigate the risk of the development plan for fosgonimeton, support the potential clinical benefit of fosgonimeton, and inform the sample size needed for success with LIFT-AD. “said Mark Litton. , Ph.D., President and CEO of Athira. “We now aim to complete listing in mid-2023 and report key data in early 2024. Importantly, we have a strong track record to execute our plans through key data reads and further of the. Going forward, we remain very focused on advancing this new experimental therapy in hopes of positively impacting the lives of millions of patients with Alzheimer’s disease.
“Our goal with fosgonimeton is to demonstrate its ability to improve cognition and function and ultimately provide neuroprotection. The ACT-AD study suggested these benefits, and the results of the LIFT-AD interim analysis support these findings,” added Dr. Litton. “We believe that any drug that can demonstrate neuroprotection could become a treatment of choice for patients with mild to moderate Alzheimer’s.”
Live webcastAthira will host a live webcast to discuss the LIFT-AD interim analysis in more detail at 8:30 a.m. EST today, Monday, October 17, 2022. To access the live webcast, please visit https://us02web.zoom.us/webinar/register/WN_AtJ3jgG1RtmRRlcU_cYb-Q or the “Events and Presentations” page of the Investors section of the Athira website: https://investors.athira.com/news-and-events/events-and-presentations-investor. An archived replay will also be available on the website for at least 90 days after the event.
About the LIFT-AD Clinical StudyLIFT-AD is a randomized, double-blind, placebo-controlled, parallel-group study of fosgonimeton for patients with mild to moderate Alzheimer’s disease. Patients are randomized into two dose groups and a placebo group on a 1:1:1 basis to receive a subcutaneous injection of fosgonimeton or placebo once daily for 26 weeks of treatment. The primary endpoint of LIFT-AD is the Global Statistical Test, an unweighted composite score comprising measures of cognition (Alzheimer’s Disease Assessment Scale-Cognitive Subscale [ADAS-Cog11]) and function (Alzheimer’s Disease Cooperative Study-Activities of Daily Living [ADCS-ADL23]). Additional information on the LIFT-AD study is available at: NCT04488419.
About Fosgonimone Fosgonimeton 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. In addition to Alzheimer’s disease, fosgonimeton has the potential to treat the entire dementia population, including Parkinson’s disease dementia and Lewy body dementia, as the mode of action is focuses on network recovery and synaptic signal transmission in the brain.
The ACT-AD trial was supported by a grant from the National Institutes of Health’s National Institute on Aging under award number R01AG06268. The information presented in this press release is the sole 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, WA area, is a late-stage 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 through its novel mechanism of action. Athira is currently advancing its pipeline of therapeutic candidates targeting the HGF/MET neurotrophic system for the dementias of Alzheimer’s and Parkinson’s disease, dementia with Lewy bodies and neuropsychiatric indications. 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 communication 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 facts. and include statements regarding fosgonimeton as a potential treatment for Alzheimer’s disease, Parkinson’s disease dementia, Lewy body dementia, and other dementias; Athira’s technology platform and potential therapies; future development plans; clinical and regulatory objectives and their timing; expectations regarding the potential efficacy and commercial potential of Athira’s product candidates; the planned communication of the data; potential learnings from the ACT-AD trial and LIFT-AD interim efficacy and futility analysis and their ability to inform and improve future clinical development plans; and Athira’s ability to advance its product candidates to later stages of development. Forward-looking statements generally include statements that are predictive in nature and depend on or refer to future events or conditions, and include words such as “may”, “will”, “should”, “on track”, ” should”, “expect”, “plan”, “believe”, “intend”, “pursue”, “continue” and other similar expressions, among others. All forward-looking statements are based on management’s current expectations regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those stated or implied. by these forward-looking statements. These risks and uncertainties include, but are not limited to, data on our product candidates from preclinical and clinical trials will not support the safety, efficacy and tolerability of our product candidates; the termination or delay of any of Athira’s ongoing clinical trials and/or development of fosgonimeton and other product candidates may occur; regulatory authorities may object to protocols, amendments and other submissions, potential future regulatory milestones of fosgonimeton and other product candidates, including those related to ongoing and planned clinical studies, may be insufficient to support regulatory submissions or approval; the impact of the COVID-19 pandemic on Athira’s business, research and clinical development plans and schedules, and the regulatory process for Athira’s product candidates; Athira may not be able to enroll enough patients for its clinical trials; the outcome of legal proceedings that have been or may be brought in the future against us and certain of our directors and officers; clinical trials may not demonstrate the safety and efficacy of any of Athira’s product candidates; possible adverse interactions of Athira’s product candidates with other treatments; Athira’s assumptions regarding the adequacy of its cash, cash equivalents and investments to fund its planned operations may be incorrect; adverse conditions in domestic and global economic markets generally; the impact of competition; regulatory agencies may be delayed in reviewing, commenting on or approving any of Athira’s clinical development plans due to the COVID-19 pandemic, which could further delay development timelines; the impact of expanding product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; as well as 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 any forward-looking statements. Athira may not achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on any forward-looking statements.
Investor and media contact:
Julie Rathbun Athira Pharma [email protected] 206-769-9219
Source: Athira Pharma, Inc.