Coya Therapeutics Announces that Results from a Double-Blind Placebo-Controlled Study in Alzheimer’s Disease will be presented on October 29, 2024 at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in Madrid

Rhea-AI Summary

Coya Therapeutics (NASDAQ: COYA) has announced that results from a double-blind, placebo-controlled phase 2 clinical trial of interleukin-2 (IL-2) in patients with mild to moderate Alzheimer's Disease will be presented at the Clinical Trials on Alzheimer's Disease Conference (CTAD24) in Madrid on October 29, 2024. The study, conducted at Houston Methodist Research Institute and supported by the Gates Foundation and Alzheimer's Association, evaluated 38 patients over 30 weeks. This presentation replaces the previously announced topline data release planned for Summer 2024. A prior open-label study showed that low-dose IL-2 was well-tolerated and resulted in significant improvements in cognitive function and regulatory T cell (Treg) function and numbers in AD patients.

Positive

• Phase 2 clinical trial results to be presented at a major Alzheimer's Disease conference
• Previous open-label study showed significant improvements in cognitive function and Treg function in AD patients
• Study supported by prominent organizations (Gates Foundation and Alzheimer's Association)

Negative

• Delay in initial topline data presentation from Summer 2024 to October 2024

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

1. Alzheimer’s Association (www.alz.org).
2. 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<0.01), suggesting enhanced and durable Treg suppressive function over the course of treatment. In contrast, Treg suppressive function (mean ±SD) was significantly decreased at the end of the 8-week washout period compared to end-of-treatment at week 48 (70.3 ±8.1 vs. 89.5 ±4.1, p <0.05).

The study also evaluated serum biomarkers of inflammation, oxidative stress, and lipid peroxides. The available data up to 16 weeks after initiation of treatment suggest a decrease in these biomarker levels, which is consistent with the observed enhancement of Treg function. The evaluation of the full biomarker data is ongoing.

COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency.

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 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 302 – the Company’s lead biologic investigational product or “Pipeline in a Product”– is a proprietary combination of COYA 301 (Coya’s proprietary LD IL-2) and CTLA4-Ig for subcutaneous administration with a unique dual mechanism of action that is now being developed for the treatment of Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s Disease. Its multi-targeted approach enhances the number and anti-inflammatory function of Tregs and simultaneously lowers the expression of activated microglia and the secretion of pro-inflammatory mediators. This synergistic mechanism may lead to the re-establishment of immune balance and amelioration of inflammation in a sustained and durable manner that may not be achieved by either low-dose IL-2 or CTLA4-Ig alone.

For more information about Coya, please visit www.coyatherapeutics.com

Forward-Looking Statements

This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; ; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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Investor

David Snyder, CFO

david@coyatherapeutics.com

CORE IR

Bret Shapiro

brets@coreir.com

561-479-8566

Media

For Coya Therapeutics:

Kati Waldenburg

media@coyatherapeutics.com

212-655-0924

Source: Coya Therapeutics, Inc.

FAQ

What are the key details of Coya Therapeutics' (COYA) Alzheimer's Disease clinical trial?

Coya Therapeutics' (COYA) Alzheimer's Disease trial is a double-blind, placebo-controlled phase 2 study evaluating low-dose interleukin-2 (IL-2) in 38 patients with mild to moderate Alzheimer's Disease over 30 weeks. The study was conducted at Houston Methodist Research Institute and supported by the Gates Foundation and Alzheimer's Association.

When and where will Coya Therapeutics (COYA) present the results of their Alzheimer's Disease trial?

Coya Therapeutics (COYA) will present the results of their Alzheimer's Disease trial on October 29, 2024, at the Clinical Trials on Alzheimer's Disease Conference (CTAD24) in Madrid, Spain.

What were the results of Coya Therapeutics' (COYA) previous open-label study in Alzheimer's Disease?

Coya Therapeutics' (COYA) previous open-label, proof-of-concept study in eight Alzheimer's Disease patients showed that low-dose IL-2 treatment was well-tolerated and resulted in statistically significant improvements in cognitive function and significant enhancement of regulatory T cell (Treg) function and numbers.

How has the timeline for Coya Therapeutics' (COYA) Alzheimer's Disease trial data presentation changed?

Coya Therapeutics (COYA) initially announced that topline data from the Alzheimer's Disease trial might be presented in Summer 2024. However, the entire dataset will now be presented at the CTAD24 conference on October 29, 2024, in Madrid, Spain.