Coya had previously announced that initial topline data from this Investigator Initiated Trial (IIT) may be presented in Summer 2024. The Houston Methodist Research Institute investigators responsible for this IIT will instead be presenting the entire dataset at the CTAD24 peer reviewed medical conference in Madrid, Spain
This IIT, a double-blind, placebo-controlled study (funded by the Gates Foundation and Alzheimer’s Association), evaluated the safety and tolerability, biological activity, and preliminary efficacy of low-dose interleukin-2 (LD IL-2) in 38 patients with mild-to-moderate Alzheimer’s disease (AD) over 30 weeks
Previously presented data, accessed here, from an open-label, proof-of-concept study in eight AD patients illustrated that treatment with LD IL-2 was well tolerated and resulted in a statistically significant improvement in cognitive function relative to baseline and significant enhancement of regulatory T cell (Treg) function and numbers
HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function announces that data from the IIT, a double-blind, placebo-controlled, phase 2 clinical trial of interleukin-2 (IL-2) in patients with mild to moderate Alzheimer's Disease, conducted at Houston Methodist Research Institute and supported by the Gates Foundation and the Alzheimer’s Association will be presented at the 17th edition of the Clinical Trials on Alzheimer’s Disease Conference (CTAD24), to be held in Madrid, Spain on October 29 - November 1, 2024. The agenda for the conference can be accessed here.
Dr. Alireza Faridar, Professor of Neurology at Houston Methodist and Principal Investigator, commented: “I am eagerly looking forward to the opportunity to present a comprehensive dataset at Alzheimer’s Disease focused conference, the CTAD24. I thank the patients, their families as well as the Gates Foundation, Alzheimer’s Association, and Coya Therapeutics for their support in this study.”
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
- Alzheimer’s Association (www.alz.org).
- Centers for Disease Control and Prevention (www.cdc.gov).
About COYA 301 COYA 301 is the company’s proprietary investigational low-dose interleukin-2 (IL-2) intended to enhance the anti-inflammatory function regulatory T cells (Tregs) and is designed for subcutaneous administration. COYA 301 is an investigational product not yet approved by the FDA or any other regulatory agency.
About COYA 302 COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 is comprised of proprietary low dose interleukin-2 (LD IL-2) and CTLA4-Ig and is being developed for subcutaneous administration for the treatment of patients with ALS, FTD, and PD. These mechanisms may have additive or synergistic effects.
In February of 2023, Coya announced results from a proof-of-concept, open-label clinical study evaluating commercially available LD IL-2 and CTLA4-Ig in a small cohort of patients with ALS conducted at the Houston Methodist Research Institute (Houston, Texas) by Stanley Appel, M.D., Jason Thonhoff, M.D., Ph.D., and David Beers, Ph.D. This study was the first-of-its-kind evaluating this dual-mechanism immunotherapy for the treatment of ALS. Patients in the study received investigational treatment for 48 consecutive weeks and were evaluated for safety and tolerability, Treg function, serum biomarkers of oxidative stress and inflammation, and clinical functioning as measured by the ALSFRS-R scale.
During the 48-week treatment period, the therapy was well tolerated. The most common adverse event was mild injection-site reactions. No patient discontinued the study, and no deaths or other serious adverse events were reported.
Patients' disease progression was measured using the ALSFRS-R scale, a validated rating tool for monitoring the progression of disability in patients with ALS. The mean (±SD) ALSFRS-R scores at week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of treatment were not statistically different compared to the ALSFRS-R score at baseline (33.5 ±5.9), suggesting significant amelioration in the progression of the disease over the 48-week treatment period.
Treg suppressive function, expressed as percentage of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase over the course of the treatment period and was significantly reduced at the end of the 8-week washout post-treatment period. Treg suppressive function at 24 weeks (79.9 ±9.6) and 48 weeks (89.5 ±4.1) were significantly higher compared to baseline (62.1 ±8.1) (p