Fosgonimeton treatment-related reductions in biomarkers of neurodegeneration (NfL) and neuroinflammation (GFAP) significantly correlated with improvements in clinical outcomes as assessed by the GST, a composite score of cognition (ADAS-Cog11) and function (ADCS-ADL23)
Data demonstrate fosgonimeton treatment significantly improved NfL, a biomarker of neurodegeneration and showed directional improvements in biomarkers of neuroinflammation (GFAP, YKL-40) and Alzheimer’s protein pathologies (Aβ 42/40 ratio, p-Tau181) compared with placebo among patients not taking acetylcholinerase inhibitors
Totality of data suggests fosgonimeton’s potential as a neuroprotective, potentially disease-modifying, therapy for mild-to-moderate Alzheimer’s disease
BOTHELL, Wash., Nov. 29, 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 the presentation of additional biomarker data from the completed, exploratory ACT-AD Phase 2 study of fosgonimeton (ATH-1017) in patients with mild-to-moderate Alzheimer’s disease (AD) at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference.
The late-breaking poster presentation highlights the effect of fosgonimeton treatment on biomarkers associated with neurodegeneration (NfL), neuroinflammation (GFAP, YKL-40), and Alzheimer’s specific protein pathologies (Aβ 42/40 ratio and p-Tau181).
“These additional biomarker data provide further support of the therapeutic potential of fosgonimeton in patients with mild-to-moderate Alzheimer’s disease,” said Hans J. Moebius, M.D., Ph.D., Chief Medical Officer of Athira Pharma. “Our analyses of the completed, exploratory ACT-AD study found that among patients not on concomitant acetylcholinerase inhibitors, fosgonimeton treatment improved levels of serum biomarkers known to be associated with neurodegeneration and neuroinflammation. Furthermore, directional improvements in key biomarkers associated with Alzheimer’s disease pathology, Aβ 42/40 ratio and p-Tau181, provide evidence supporting fosgonimeton’s potential as a disease-modifying therapy.”
“Notably, in the context of clinical outcomes, these biomarker data showed that fosgonimeton treatment-related reductions in NfL and GFAP significantly correlate with improvements in the GST, a composite score of cognition and function,” added Dr. Moebius.
Key findings from the presentation include:
- Baseline NfL (neurodegeneration) levels may predict functional decline in patients with mild-to-moderate AD as assessed by the change from baseline measures of ADCS-ADL23.
- Fosgonimeton treatment significantly reduced levels of NfL (neurodegeneration, p=0.0241) and numerically reduced levels of GFAP and YKL-40 (neuroinflammation).
- Fosgonimeton treatment showed directional improvements in biomarkers of AD-associated protein pathologies (Aβ 42/40 ratio and p-Tau181) compared to placebo.
- Fosgonimeton treatment-related reductions in NfL and GFAP significantly correlated with improvements in clinical outcomes, as assessed by the Global Statistical Test (GST), a composite score of ADAS-Cog11 and ADCS-ADL23.
“These compelling biomarker data provide further evidence that supports the ongoing development of fosgonimeton and our pipeline of HGF/MET-modulating compounds,” said Mark Litton, Ph.D., Chief Executive Officer of Athira Pharma. “Our clinical and preclinical data continue to support the potential neuroprotective and disease-modifying properties of enhancing the HGF/MET neurotrophic system. We are excited by our progress with the ongoing Phase 2/3 LIFT-AD clinical study of fosgonimeton in this same patient population and look forward to completing enrollment of this potentially pivotal study in mid-2023 with topline data in early 2024.”
The presentation is available on the Scientific Publications & Presentations page of the company’s website at www.athira.com.
The ACT-AD trial was 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 is solely the responsibility of Athira and does not necessarily represent the official views of the National Institutes of Health.
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 address the broader dementia population, including Parkinson’s disease dementia and Dementia with Lewy bodies, as the mode of action focuses on network recovery and synaptic signal transmission in the brain.
About Athira Pharma, Inc.
Athira Pharma, Inc., headquartered in the Seattle, Washington 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 pipeline of therapeutic candidates targeting the HGF/MET neurotrophic system for Alzheimer’s and Parkinson’s disease dementia, 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.
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