Coya Updates Enrollment for Phase 1 Study of LD IL-2 + CTLA4-Ig in FTD Patients

Coya Therapeutics, Inc., a biotechnology company listed on NASDAQ, is advancing its research in the field of neurodegenerative diseases through innovative treatments aimed at enhancing the function of regulatory T cells (Tregs). The company has enrolled five out of an intended eight participants in an academic study on a novel therapy combining low-dose interleukin-2 (LD IL-2) with CTLA4-Ig for patients diagnosed with Frontotemporal Dementia (FTD). This study, spearheaded by Dr. Stanley Appel and Dr. Alireza Faridar at Houston Methodist Hospital, seeks to assess various clinical outcomes, including safety, patient tolerability, changes in Treg cell populations, inflammation levels, and the progression of FTD symptoms.

This investigational therapy, known as COYA 302, leverages a dual mechanism involving LD IL-2 and CTLA4-Ig fusion protein, designed to modulate the immune response in FTD patients. The aim is to counteract the proinflammatory state that results from compromised Treg function, a condition observed in FTD patients. By restoring Treg levels and reducing inflammation, COYA 302 could potentially slow or alter disease progression.

The ongoing study aims to provide crucial data that will shape the design of a subsequent, larger Phase 2 trial. This trial will be a double-blinded, randomized study sponsored by Coya Therapeutics. This larger trial will further explore the therapeutic potential of COYA 302 in FTD patients, supported by a $5 million grant from the Alzheimer’s Drug Discovery Foundation (ADDF).

FTD is a challenging neurodegenerative disorder that affects the frontal and temporal lobes of the brain. It presents with a variety of symptoms, such as unusual behaviors, emotional disturbances, and communication difficulties. FTD primarily affects individuals aged between 45 and 64, and it follows a progressive course, with symptoms worsening over time. Currently, there are no definitive treatments to halt or reverse FTD, underscoring the importance of research into new therapeutic avenues like COYA 302.

The foundational concept of COYA 302 is its dual-action approach, which not only aims to boost Treg numbers and activity but also targets the inflammation pathway. This multi-targeted strategy could potentially address the complex immune imbalances seen in FTD and other neurodegenerative diseases, thereby offering a novel treatment pathway where none currently exists.

In earlier research presented at a medical conference, data showed that patients with FTD had significantly reduced Treg function, with increased levels of inflammatory cytokines and chemokines, highlighting the critical role of immune dysfunction in the disease. These findings support the rationale for using a combination therapy like COYA 302, which aims to modulate multiple aspects of the immune system.

Coya Therapeutics continues to develop its pipeline with innovative treatments that focus on the modulation of Tregs to combat neuroinflammation and systemic inflammation. With COYA 302 at the forefront, the company is dedicated to addressing unmet needs in neurodegenerative diseases, with potential applications extending beyond FTD to conditions such as ALS, Parkinson’s, and Alzheimer’s disease. The ongoing research and development efforts highlight Coya's commitment to advancing therapeutic solutions for these complex disorders.