BERWYN, PA — In a recent breakthrough, Annovis Bio (NYSE: ANVS), a biopharmaceutical company, has successfully performed measurements of critical biomarkers in the plasma of Parkinson’s disease patients. Utilizing buntanetap, Annovis Bio has been able to lower the levels of TDP43, NfL, and GFAP – key biomarkers associated with neurodegeneration.
This development has been made possible by advancements in biomarker research which now allow for the measurement of these biomarkers in plasma rather than cerebrospinal fluid (CSF). This approach significantly reduces the burden on patients while allowing researchers to monitor changes in biomarkers throughout the progression of neurodegenerative diseases.
TDP-43, or TAR DNA-binding protein 43, was first discovered by Lee & Trojanowski at the University of Pennsylvania in 2007. It was initially associated with frontotemporal dementia (FTD) and later with amyotrophic lateral sclerosis (ALS) by Shaw’s lab in King’s College London. More recently, numerous high-profile studies have linked TDP-43 with other neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD).
Dr. Ron Peterson from the Mayo Clinic highlighted in his 2018 Neurology review that protein abnormalities beyond amyloid and tau, including TDP-43 and α-synuclein, may contribute to neurodegeneration and cognitive impairment. Similar to Aβ and α-synuclein, TDP-43 is a neurotoxic aggregating protein that at normal levels performs a vital function but becomes toxic when overexpressed, impairing axonal transport, inducing inflammation, and killing nerve cells.
Two years ago, Annovis Bio discovered that buntanetap could inhibit TDP-43 expression in vitro. Recent data from their phase 2a study showed that an 80mg buntanetap treatment reduced the accumulation of TDP-43 in patients’ plasma by 71.7% compared to placebo, with a statistically significant difference. Buntanetap also demonstrated a trend in reducing the inflammatory factor GFAP (Glial fibrillary acidic protein) and the axonal damage biomarker NfL (Neurofilament-light chain).
These promising results support buntanetap’s mechanism of action of reducing overexpression of various neurotoxic proteins in disease situations. As a result, it can reduce inflammation and neuronal damage while preserving neuronal function.
“We are pleasantly surprised to see a statistically significant drop in TDP43 levels in just 10 patients and to see a strong trend in GFAP and NfL. To our knowledge, this is the first time that a drug reduces the levels of TDP43 in humans, specifically here in PD patients,” said Dr. Maccecchini, “These biomarker data not only corroborate the mechanisms of actions of buntanetap but also provide a new way to stratify patients and understand their disease pathology.”
As part of their ongoing research, Annovis Bio will measure the above biomarkers in the plasma of the patients currently participating in their phase 3 PD study. This will help determine the effect of their drug on the course of the disease over a six-month period. The findings hold significant implications for the future of Parkinson’s disease treatment, potentially paving the way for more effective therapeutic strategies.
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