Coya Therapeutics Completes Enrollment for Study on IL-2 and CTLA4-Ig for Frontotemporal Dementia

Coya Therapeutics Completes Enrollment for Frontotemporal Dementia Study

Coya Therapeutics, Inc. (NASDAQ: COYA), a biotechnology firm focused on biologics for neurodegenerative conditions, has successfully completed patient enrollment in its investigator-initiated, open-label study involving a combination treatment of low-dose IL-2 and CTLA4-Ig for patients suffering from mild to moderate Frontotemporal Dementia (FTD). The significant milestone was announced on September 29, 2025, following earlier positive interim results from five patients in April 2025. This latest trial has brought the total number of enrolled patients to nine, adhering strictly to the planned study protocol. As of now, no safety issues have been reported, indicating a promising trajectory for this critical research.

The clinical study is under the guidance of Dr. Alireza Faridar and Dr. Stanley Appel at the Houston Methodist Neurological Institute, with financial support from The Peggy and Gary Edwards Endowment Fund. All participating patients underwent a treatment regimen that involved a subcutaneous administration of CTLA4-Ig, followed by a five-day course of low-dose IL-2 every four weeks, spanning a total of 22 weeks of dose administration and follow-up.

The trial's completion is expected in the fourth quarter of 2025, with results anticipated to be delivered thereafter. After locking the database and performing a comprehensive analysis of the collected data, Coya intends to publish the findings from this essential study. The organization remains committed to addressing the high unmet medical need associated with Frontotemporal Dementia, which is regarded as a devastating neurodegenerative disease.

Understanding Frontotemporal Dementia (FTD)

Frontotemporal Dementia encompasses a group of neurodegenerative disorders characterized by marked alterations in behavior and language, along with a gradual decline in executive functions. Estimated to affect approximately 30,000 Americans, FTD is classified into various clinical subtypes consisting primarily of behavioral-variant frontotemporal dementia and two language-specific variants: semantic dementia (also referred to as semantic variant primary progressive aphasia) and progressive non-fluent aphasia (also known as non-fluent variant primary progressive aphasia). One distinctive feature of FTD is its prevalence in younger populations, often occurring between the ages of 45 to 64, with an average onset age of 58 years and an average survival timeframe of 7.5 years.

The Role of Coya Therapeutics

Coya Therapeutics, headquartered in Houston, TX, is dedicated to pioneering treatments designed to enhance the function of regulatory T cells (Tregs) that may address systemic inflammation and neuroinflammation associated with various conditions, including neurodegenerative and autoimmune diseases. The company’s product pipeline focuses on several therapeutic modalities targeted at re-establishing the anti-inflammatory and immunomodulatory functions of Tregs. These innovative therapeutic platforms comprise Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy.

actions to democratize treatment options for neurodegenerative disorders, enhancing the quality of life for affected individuals and their families. "We are honored to reach this vital milestone in our clinical trial journey. FTD remains a challenging condition with pressing treatment demands, and we are passionate about contributing to potential solutions," comments Dr. Fred Grossman, CMO of Coya Therapeutics.

The journey of transforming clinical research findings into tangible solutions for FTD remains paramount for Coya. As the company anticipates more data from ongoing trials, it also underscores its dedication to innovation in the realm of neurodegenerative treatment development.