• Alireza Faridar, MD (Houston Methodist and Weill Cornell Medical College) will present data from an open-label, proof-of-concept study in 8 AD patients treated with Low Dose IL-2 (LD IL-2) over a 4 month period that resulted in a statistically significant improvement in cognitive function, as measured by the Mini-Mental State Examination test (MMSE) and no cognitive decline as observed by the AD Assessment Scale–Cognitive Subscale (ADAS-Cog), and the Clinical Dementia Rating-Sum of Boxes scale (CDR-SB);
• It has been recently announced here that a double-blind, placebo-controlled study (funded by the Gates Foundation and Alzheimer’s Association) evaluating safety and tolerability, biological activity, relevant biomarkers, neuroimaging, and efficacy of LD IL-2 in 38 patients with mild-to-moderate AD over 30 weeks is fully enrolled and will release top line data in the first half of 2024;
• Coya’s proprietary investigational LD IL-2 (COYA 301) for subcutaneous administration has been designed to enhance the function of Tregs in vivo and is being developed as a monotherapy for the treatment of AD.

Coya 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 announced that Dr. Alireza Faridar, Assistant Professor of Neurology at Houston Methodist and Weill Cornell Medical College, will give an oral presentation at the 18th International Conference on Alzheimer’s and Parkinson’s Disease held in Lisbon, Portugal between March 5-9, 2024. Details and Registration for the conference are found here.

Dr. Faridar and team are currently conducting a double-blind, randomized, well-controlled study in 38 AD patients evaluating the safety and tolerability, biological activity, blood and cerebrospinal fluid biomarkers, neuroimaging, and changes in cognitive function of LD IL-2 compared to placebo at pre-specified timepoints over the course of a 21-week treatment period and at 9 weeks after the last dose of study treatment.

Topline results of this study are anticipated to be reported in the first half of 2024. The study is funded by the Gates Foundation and the Alzheimer’s Association.

About Alzheimer’s Disease

Alzheimer's disease is the most common cause of dementia, a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Alzheimer's disease accounts for up to 80% of dementia cases, affecting an estimated 5.7 million Americans. In more than 90% of people with Alzheimer’s, symptoms do not appear until after age 60. The incidence of the disease increases with age and doubles every 5 years beyond age 65. Alzheimer's is a progressive disease, where dementia symptoms gradually worsen over a number of years. In its early stages, memory loss is mild, but with late-stage Alzheimer's, individuals lose the ability to carry on a conversation and respond to their environment. It is the sixth leading cause of death among all adults and the fifth leading cause for those aged 65 or older. On average, a person with Alzheimer's lives 4 to 8 years after diagnosis but can live as long as 20 years, depending on other factors. ^1,2

References

1. Alzheimer’s Association (www.alz.org).
2. Centers for Disease Control and Prevention (www.cdc.gov)

About Coya Therapeutics, Inc.

Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to a sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Coya’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers. COYA 301 (LD IL-2) is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers and is currently being investigated in AD, and COYA 302 (LD-IL-2 plus CTLA4 lg) is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages currently being investigated in amyotropic lateral sclerosis (ALS). These two mechanisms may be additive or synergistic in suppressing inflammation. For more information about Coya, please visit www.coyatherapeutics.com

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