Coya Therapeutics (NASDAQ: COYA) announced it has completed patient enrollment in an investigator-initiated, open-label proof-of-concept study evaluating a combination therapy of low-dose IL-2 and CTLA4-Ig in patients with mild to moderate Frontotemporal Dementia (FTD).
Study Design and Progress
The trial, led by Dr. Alireza Faridar and Dr. Stanley Appel at the Houston Methodist Neurological Institute, enrolled a total of nine patients, following an earlier interim update in April that reported positive signals in the first five participants. Patients in the study receive subcutaneous CTLA4-Ig, followed by a five-day course of low-dose IL-2 every four weeks over a 22-week period.
According to the company, the study is advancing according to protocol with no safety issues or discontinuations reported to date. Completion is expected in the fourth quarter of 2025, with topline results to follow after database lock and analysis.
Disease Context
Frontotemporal Dementia is a group of rare neurodegenerative disorders characterized by changes in behavior, language impairment, and executive dysfunction. It affects an estimated 30,000 individuals in the United States, typically presenting between the ages of 45 and 64. Average life expectancy following diagnosis is roughly 7.5 years.
Company Commentary
Dr. Fred Grossman, Chief Medical Officer of Coya, noted that completing enrollment marks an important milestone in developing potential therapies for FTD, a disease with few treatment options. “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,” he said.
Investor Takeaways
For investors, the progress underscores Coya’s continued focus on advancing its Treg-modulating biologics platform beyond amyotrophic lateral sclerosis (ALS) into additional neurodegenerative indications. Upcoming topline results from this small proof-of-concept study could provide early validation for the company’s approach in FTD, though larger trials will be necessary to establish efficacy and regulatory pathways.
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
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