Coya Therapeutics, Inc. announced that Dr. Stanley Appel, M.D., Chairman of Coya?s Scientific Advisory Board and Dr. David Beers, Ph.D., Associate Research Professor of Neurology, Houston Methodist, will present biomarker data as part of a panel presentation at the Society of Neuroimmune Pharmacology Conference. The data presented highlights the strong predictive value of levels of an oxidative stress biomarker (4-HNE) with the rate of disease progression and survival in 50 ALS patients from a longitudinal patient registry cohort. An additional analysis of another random 50 patients from the same patient registry cohort is being finalized and will be presented in the future.

In a proof-of-concept study in patients with ALS, the combination of low dose interleukin-2 (LD IL-2) and CTLA-4 Ig appeared to lower 4-HNE and other proinflammatory biomarker levels. Coya intends to finalize the analysis of the initial 50 patients, as well as the additional 50 ALS patients,and publish the results in a peer review journal in the near future. Reactive oxygen species (ROS) are generated mainly as byproducts of mitochondrial respiration and are tightly controlled by multiple anti-oxidant mechanisms. In neurodegenerative diseases, such as ALS, when the antioxidant system is overwhelmed by overproduction of ROS, oxidative stress occurs.

4-HNE, an abundant and reactive oxygen species, is thought to exert neuronal toxicity ultimately through formation of toxic protein aggregates, such as those seen in ALS patients. Additionally, 4-HNE appears to be causally involved in multiple pathophysiologic events associated with disease pathophysiology, including motor neuron death. Summary of Study Results: Data was collected from a previously established biobank at Houston Methodist to monitor and track ALS patient outcomes with biomarkers.

Serial longitudinal sampling of serum was assessed in 50 patients over the duration of their journeys from diagnosis to death. 4-HNE was identified in previous studies as a biomarker of interest relevant to ALS pathophysiology. Thus, serum 4-HNE levels were tracked and monitored during the patients?

treatment journeys, while healthy patients were measured as controls. Results demonstrate that: 4-HNE serum levels are significantly elevated in ALS patients compared to healthy controls 4-HNE serum levels correlate with the rate of disease progression in ALS patients (ALSFRS points/month) - The higher the 4-HNE serum level, the faster the progression 4-HNE serum levels correlate with survival from onset and diagnosis to death -The higher the 4-HNE serum level, the shorter the survival A receiver operating characteristic curve (ROC) analysis documents a 91.7% sensitivity and 71.1% specificity in predicting 24-month survival based on a threshold 4-HNE level of 8 ug/ml: If 4-HNE serum levels are > 8 ug/ml, there is a 91.7% chance that patient survival will be less than or equal to 24 months. If 4-HNE serum level is < 8 ug/ml, there is a 71.1% chance that patient survival is greater than 24 months Based on a proof-of-concept study, COYA 302 (combination of LD IL-2 and CTLA-4 Ig) may lower 4-HNE levels and levels of other relevant biomarkers that correlate with disease progression.