Coya Therapeutics, Inc. (NASDAQ: COYA) has announced an enrollment update for its investigator-initiated Phase 1 study evaluating the combination of low-dose interleukin-2 (LD IL-2) and cytotoxic T lymphocyte-associated antigen 4 immunoglobulin fusion protein (CTLA4-Ig) in patients with frontotemporal dementia (FTD). The study, conducted at Houston Methodist Hospital, has enrolled five of the planned eight participants.
The open-label Phase 1 trial is designed to assess the safety, tolerability, and effects of the LD IL-2 + CTLA4-Ig combination on peripheral and central inflammation, regulatory T cell (Treg) populations, and FTD progression. Coya Therapeutics is leveraging the results from this study to refine the design of its upcoming Phase 2 trial of COYA 302 in FTD patients. COYA 302 is a proprietary formulation of LD IL-2 and CTLA4-Ig.
Rationale for COYA 302 in FTD
FTD is characterized by damage to neurons in the frontal and temporal lobes of the brain, leading to a range of symptoms including behavioral abnormalities, emotional disturbances, and communication difficulties. Currently, there are no cures or treatments to slow or halt the progression of FTD.
Tregs, which play a crucial role in suppressing inflammation and maintaining immune homeostasis, are dysfunctional in FTD patients. This dysfunction contributes to a proinflammatory state that may exacerbate disease progression. The combination of LD IL-2 and CTLA4-Ig is hypothesized to enhance Treg cell populations and reduce both peripheral and central inflammation through additive or synergistic mechanisms.
Prior Clinical Findings
Data presented at the AD/PD 2024 Conference demonstrated significantly reduced Treg suppressive function in FTD patients compared to healthy controls (p<0.01). This finding underscores the impaired immunomodulatory function of Tregs in FTD and supports the rationale for targeting immune dysfunction in this neurodegenerative disease.
COYA 302: A Dual-Action Immunomodulator
COYA 302 is an investigational biologic combination therapy designed to enhance Treg function and suppress inflammation. It comprises LD IL-2, which promotes Treg expansion and activity, and CTLA4-Ig, which blocks T cell activation and reduces inflammation. This dual mechanism of action aims to re-establish immune balance and mitigate inflammation in a sustained manner.
Fred Grossman D.O., President and CMO of Coya, stated, "We plan to submit an IND for FTD, and the data from the investigator-initiated study will inform some design features of this planned trial. COYA 302 has potential therapeutic application in a variety of neurodegenerative diseases, starting with ALS and FTD."
