Coya:Inflammation,oxidative stress may play role in severity/progression of ALS

Coya Therapeutics, 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 reports the analyses of blood biomarker data from a cross sectional cohort of sporadic ALS patients and healthy controls and from two investigator-initiated clinical studies . In the IIT studies, patients were treated with expanded Treg cell therapy in combination with low-dose interleukin-2 . As previously reported, patients from these two trials experienced amelioration of disease progression with corresponding increased Treg numbers and suppressive function. Evidence 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. Following these encouraging results, Coya plans to assess blood markers of oxidative stress and inflammation systematically and prospectively in the upcoming well powered placebo controlled clinical study of COYA 302 in patients with ALS, aiming to provide a better understanding of the disease, with the ultimate goal of developing consistent biomarkers to evaluate treatment response.