Coya Therapeutics, Inc. (NASDAQ: COYA), a clinical-stage biotech company, announced that five of eight patients have been enrolled in an investigator-initiated academic study of the LD IL-2 + CTLA4-Ig combination for treating Frontotemporal Dementia (FTD). The study is led by Drs. Stanley Appel and Alireza Faridar at Houston Methodist Hospital. The study’s topline results will help finalize the design of a Phase 2 trial of COYA 302 for FTD. Coya has received $5 million from the Alzheimer’s Drug Discovery Foundation (ADDF) to support COYA 302’s development in FTD.
The investigator-initiated study evaluating the combination of low-dose interleukin-2 (LD IL-2) and CTLA4-Ig fusion protein (COYA 302) in Frontotemporal Dementia (FTD) patients is assessing key parameters including safety, tolerability, Treg cell populations, inflammation, and disease progression. COYA 302, a proprietary biologic therapy developed by Coya Therapeutics, is designed to enhance Treg cell function and reduce inflammation. It combines LD IL-2 and CTLA4-Ig to target immune system dysfunction observed in neurodegenerative diseases like FTD.
Fred Grossman, D.O., President and CMO of Coya, shared that the data from this investigator-initiated study will be pivotal in designing Coya’s planned Phase 2 trial of COYA 302 for FTD. Coya also aims to submit an Investigational New Drug (IND) application for FTD, and the findings will inform aspects of trial design. The company’s focus is on leveraging COYA 302 as a potential treatment not only for FTD but also for other neurodegenerative diseases such as ALS.
FTD patients exhibit dysfunctional Treg cells, which contribute to a pro-inflammatory immune state that may accelerate disease progression. The combination of LD IL-2 and CTLA4-Ig has shown promise in enhancing Treg cell populations and reducing peripheral and central inflammation. Treg cells are vital for regulating immune responses, and their dysfunction is believed to play a critical role in FTD’s pathophysiology.
Data presented by the research team at the AD/PD 2024 Conference demonstrated that Treg suppressive function was significantly reduced in FTD patients compared to controls. This dysfunction, along with elevated inflammatory cytokines and chemokines, highlights the importance of the immune system in the progression of FTD. Coya has previously reported similar immune system dysfunctions in other neurodegenerative diseases, reinforcing the potential of COYA 302’s multi-pathway approach to targeting immune system irregularities. The combination therapy aims to address these issues by both improving Treg function and reducing inflammation.
The SAFE-D study, part of the ongoing investigation, focuses on understanding whether the combination therapy can detect early signals of pancreatic cancer in patients diagnosed with type 2 diabetes. The study is expected to provide key insights that will inform Coya’s approach to expanding the therapeutic potential of COYA 302 in a variety of neurodegenerative conditions.
About Frontotemporal Dementia (FTD)
Frontotemporal dementia is a progressive neurodegenerative disease that damages neurons in the brain’s frontal and temporal lobes. Symptoms can include behavioral changes, difficulty communicating, emotional issues, and problems with motor functions. FTD typically affects individuals aged 45 to 64 and is characterized by its rapid progression. The disease often worsens over time, with some individuals living more than a decade after diagnosis, while others have a much shorter lifespan. Currently, there is no cure for FTD, and no treatments can slow or stop its progression.
