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Coya Therapeutics Announces Publication of Potential Novel Blood Biomarker Data in Amyotrophic Lateral Sclerosis (ALS) Patients That Accurately Reflect Therapeutic Responses When Treated with Regulatory T Cell (Treg) Enhancing Therapies
Pathological hallmarks of ALS are characterized by alterations in inflammation and oxidative stress, with oxidative stress playing a critical role in
About this update from Coya Therapeutics, Inc.
[{"type":"text","content":"\n\nPathological hallmarks of ALS are characterized by alterations in inflammation and oxidative stress, with oxidative stress playing a critical role in neuronal damage.\n\n\n\n4-hydroxy-2-nonenal (4-HNE) is a key mediator of oxidative stress in cells and tissues.\n\n\n\nAnalysis of blood biomarker data from two clinical trials of Treg-enhancing therapies in patients with ALS demonstrated a strong correlation between clinical response and levels of 4-HNE and inflammatory biomarkers monocyte chemoattractant protein-1 (CCL2) and interleukin (IL-18).\n\n\n\nCoya intends to leverage these correlative biomarkers in its planned fully powered placebo controlled clinical trial with COYA 302 in patients with ALS.\n\n\n\n HOUSTON--(BUSINESS WIRE)--\nCoya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic platforms intended to enhance Treg function, including biologics and cell therapies, today reported the publication of a research article entitled “Immunological, Oxidative, and Structural Factors and Their Responses to Regulatory T Lymphocyte Therapy in Amyotrophic Lateral Sclerosis” in the peer-reviewed journal Ageing and Neurodegenerative Diseases. The publication can be accessed here.\n\n\nThe publication reports the analyses of blood biomarker data from a cross sectional cohort of sporadic ALS patients (n = 30) and healthy controls (n=10) and from two investigator-initiated clinical studies (IIT) (n=11). In the IIT studies, patients were treated with expanded Treg cell therapy in combination with low-dose interleukin-2 (IL-2). As previously reported, patients from these two trials experienced amelioration of disease progression with corresponding increased Treg numbers and suppressive function.\n\n\nEvidence strongly supports the role of inflammation and oxidative stress in the severity and rate of disease progression in ALS. These new biomarker data demonstrate that enhancing Treg function improves clinical outcomes with accompanying changes in blood levels of oxidative stress markers, such as 4-HNE, and inflammatory markers, including CCL2 and IL-18, and may have the potential to serve as objective biomarkers of disease progression and clinical trial endpoint surrogates to therapies that enhance Treg function.\n\n\nStanley Appel, M.D., Chairman of Coy...