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
News Market Reaction – COYA
On the day this news was published, COYA gained 3.10%, reflecting a moderate positive market reaction. Argus tracked a peak move of +3.0% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $3M to the company's valuation, bringing the market cap to $99M at that time.
Data tracked by StockTitan Argus on the day of publication.
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
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
- Knopman et al. Development of methodology for conducting clinical trials in frontotemporal lobar degeneration. Brain 2008; 131(11): 2957-2968.
- 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
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
David
david@coyatherapeutics.com
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917-415-1750
Media Contacts
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SOURCE Coya Therapeutics, Inc.
FAQ
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