Coya Therapeutics Announces Completion of Patient Enrollment of an Investigator-Initiated, Open-Label Study with Low-Dose IL-2 and CTLA4-Ig Combination Treatment in Patients with Mild to Moderate Frontotemporal Dementia

Rhea-AI Summary

Coya Therapeutics (NASDAQ:COYA) has completed patient enrollment in an investigator-initiated, open-label study evaluating a combination treatment of low-dose IL-2 and CTLA4-Ig in patients with mild to moderate Frontotemporal Dementia (FTD). The study, conducted at Houston Methodist Neurological Institute, has successfully enrolled all 9 planned patients.

Following positive interim results from 5 patients announced in April 2025, the trial added 4 more patients. The treatment involves subcutaneous CTLA4-Ig administration followed by a 5-day course of low-dose IL-2 every four weeks, for 22 weeks of dosing and follow-up. The study has reported no serious adverse events or safety-related discontinuations and is expected to complete in Q4 2025 with topline results to follow.

Positive

• No serious adverse events or safety-related discontinuations reported in the trial
• Successfully completed enrollment of all 9 planned patients
• Study is progressing according to protocol following positive interim results

Negative

• Results are still pending and efficacy remains unproven
• Small patient population size (9 patients) may limit statistical significance

Insights

Neuroscience Clinical Researcher

Coya's FTD study enrollment completion signals progress toward potential therapeutic breakthrough in a disease with no approved treatments.

The completion of enrollment for Coya Therapeutics' investigator-initiated study represents a meaningful milestone in their clinical development program. This study, examining a combination of low-dose IL-2 and CTLA4-Ig in frontotemporal dementia (FTD) patients, builds on previously announced positive interim results in 5 patients from April 2025. The trial has now enrolled all 9 planned participants, suggesting the company has maintained its clinical timelines.

The absence of reported safety issues is particularly encouraging. Immunomodulatory approaches like this combination therapy carry inherent risks of immune-related adverse events, so clean safety data thus far supports the tolerability of this regimen in the FTD population. The expectation for study completion in Q4 2025 keeps Coya on track for important data readouts.

The scientific rationale behind this approach is compelling. The combination targets regulatory T cell (Treg) enhancement through complementary mechanisms - IL-2 expands Tregs while CTLA4-Ig modulates T cell activation. This dual-action approach may address the neuroinflammation contributing to FTD pathology more effectively than single-target therapies.

FTD represents a severe unmet medical need as the most common form of dementia in patients under 60, with no FDA-approved treatments. Current options are limited to symptom management without addressing disease progression. The investigator-initiated nature of this trial reflects academic interest in Coya's approach, providing external validation while reducing company R&D costs.

Following the positive interim results in 5 patients announced earlier this year, a total of 9 patients have been enrolled as planned

The study is progressing according to protocol, and no safety issues have been reported

Study completion is anticipated in Q4 2025 with topline to follow

HOUSTON, Sept. 29, 2025 /PRNewswire/ -- Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announces completion of patient enrollment of an investigator-initiated, proof-of-concept, open-label study with low-dose IL-2 and CTLA4-Ig combination treatment in patients with Frontotemporal Dementia (FTD). The study is led by Dr. Alireza Faridar and Dr. Stanley Appel at the Houston Methodist Neurological Institute (Houston, TX) with funding from The Peggy and Gary Edwards Endowment Fund. Study patients received subcutaneously administered CTLA4-Ig, followed by a 5-day course of low-dose IL-2 every four weeks, for a total of 22 weeks of dosing and follow-up.

Following the positive interim results of 5 patients announced in April 2025, the study has enrolled an additional 4 patients for a total of 9 FTD patients. The trial is progressing according to the study protocol and no serious adverse events or discontinuations due to safety issues have been reported.  Study completion is anticipated in Q4 2025 with topline to follow. Following database lock and analysis of the data, the Company plans to release the results of the study.

"We are pleased to announce the completion of this important clinical milestone. FTD is a devastating neurodegenerative disease of high unmet need. We remain committed to developing an effective and safe treatment for this rare form of dementia," Dr. Fred Grossman, CMO commented.

About Frontotemporal Dementia
Frontotemporal dementia (FTD) refers to a group of neurodegenerative disorders characterized by altered behavior and language, with a progressive decline in executive function.¹ FTD affects an estimated 30,000 Americans.² FTD is categorized clinically into various subtypes; the main three include behavioral-variant frontotemporal dementia and two language variants, semantic dementia (also known as semantic variant primary progressive aphasia) and progressive non-fluent aphasia (also known as non-fluent variant primary progressive aphasia). FTD is a presenile dementia, meaning it can occur in younger individuals, often between the ages of 45 and 64. The average age of onset is 58, with an average survival time of 7.5 years.^1,2

References

1. Knopman et al. Development of methodology for conducting clinical trials in frontotemporal lobar degeneration. Brain 2008; 131(11): 2957-2968.
2. Rascovsky et al. Rate of progression differs in frontotemporal dementia and Alzheimer disease. Neurology 2005; 65(3): 397-403.

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. 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.

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.

Investor Contact  
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david@coyatherapeutics.com

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SOURCE Coya Therapeutics, Inc.

FAQ

What is the status of COYA's Frontotemporal Dementia clinical trial?

Coya Therapeutics has completed enrollment of 9 patients in their FTD trial testing low-dose IL-2 and CTLA4-Ig combination treatment, with study completion expected in Q4 2025.

How many patients are enrolled in COYA's FTD study?

The study has enrolled a total of 9 patients, including 5 patients from the initial interim analysis and 4 additional patients.

What is the treatment protocol in COYA's Frontotemporal Dementia trial?

Patients receive subcutaneous CTLA4-Ig followed by a 5-day course of low-dose IL-2 every four weeks, for a total of 22 weeks of dosing and follow-up.

Have there been any safety concerns in COYA's FTD clinical trial?

No serious adverse events or safety-related discontinuations have been reported in the trial to date.

When will COYA release results from their FTD clinical trial?

The study is expected to complete in Q4 2025, with topline results to be released following database lock and data analysis.