HOUSTON - Coya Therapeutics, Inc. (NASDAQ: COYA), a biotech firm specializing in regulatory T cell function enhancement, announced key biomarker data at the Society of Neuroimmune Pharmacology Conference today. The data underscore the potential of 4-Hydroxynonenal (4-HNE) levels as a predictive marker for Amyotrophic Lateral Sclerosis (ALS) progression and patient survival.
The study, which involved 50 ALS patients from a longitudinal patient registry cohort, revealed that 4-HNE levels in serum are significantly higher in ALS patients compared to healthy controls. Furthermore, these levels showed a strong correlation with the rate of disease progression and survival, with a 91.7% sensitivity and 71.1% specificity in predicting 24-month survival based on a threshold level of 4-HNE.
Coya's research suggests that 4-HNE could be a valuable surrogate biomarker to track the efficacy of ALS disease-modifying treatments. This includes COYA 302, a combination therapy of low dose interleukin-2 and CTLA-4 Ig, which in a proof-of-concept study appeared to lower 4-HNE and other proinflammatory biomarker levels.
Dr. Stanley Appel, Chairman of Coya’s Scientific Advisory Board, expressed optimism about the correlation of 4-HNE with disease progression and patient survival, supporting its potential importance as a biomarker. In light of the biomarker data's strength, Coya plans to engage with the FDA to discuss validating 4-HNE as a new potential biomarker for ALS progression and survival prediction.
ALS, also known as Lou Gehrig's Disease, is a rare, progressive neurological disease with no cure and limited treatment options. It affects motor neurons, leading to muscle weakness, atrophy, and eventually respiratory failure. The disease's progression is typically monitored using the Revised ALS Function Rating Scale (ALSFRS-R).
Coya Therapeutics is committed to developing treatments that target systemic inflammation and neuroinflammation. Their lead investigational product, COYA 302, aims to enhance the anti-inflammatory function of regulatory T cells and suppress inflammation produced by activated monocytes and macrophages.
The company is developing COYA 302 for various neurodegenerative diseases, including ALS, Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s Disease.
The information presented in this article is based on a press release statement from Coya Therapeutics.
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