Coya Therapeutics announced positive interim results for its clinical trial for a potentially disease-modifying treatment course for FTD, citing data showing that it helped to prevent cognitive decline.

Therapeutics Address Compromised Regulatory T Cell Function in FTD

Previous studies by researchers at Coya and elsewhere have revealed the role of regulatory T cell (treg) dysregulation in FTD and other dementias. Normally, tregs help moderate and maintain the immune system by preventing immune cells from attacking each other and by controlling inflammation. In FTD, treg levels are lowered, which can lead to inflammation and a constant, harmful activation of immune cells.

To address this dysfunction, Coya developed two therapeutics, IL-2 and CTLA4-lg, which address different features of FTD-related pathology. The drug IL-2 assists in the development, expansion, and survival of tregs, while CTLA4-lg selectively depletes activated immune cells. In the trial, participants received a single dose of CTLA4-lg, followed by a five-day course of IL-2 every four weeks for 22 weeks.

Interim results from the trial show that the drugs were well tolerated by its five participants, who, on average, showed little to no cognitive decline throughout the study. Treg levels increased after the first treatment regimen, restoring some immune system moderation. Treg levels remained elevated throughout the treatment period.

“We are excited with the results observed in this initial group of patients with this proof-of-concept study,” said Coya Therapeutics president and chief medical officer Fred Grossman, DO, FAPA. “We believe that the increase in treg numbers and suppressive function, with subsequent anti-inflammatory biological activity still to be evaluated, underscores the potential for this low-dose IL-2/CTLA4-Ig combination to be further studied as a therapy for FTD, for which there are no currently approved treatments.”

The company aims to enroll an additional five participants to take part in another round of dosing later this year. To participate in the trial, participants must have a diagnosis of probable FTD and a care partner who can assist them and provide additional data for researchers, among other requirements. The trial is being conducted at Houston Methodist Research Institute in Texas; for more information, visit this study’s clinicaltrials.gov page.

Are you interested in participating in FTD research? The FTD Disorders Registry can not only connect you with studies, but also provide a platform to share your experiences to guide researchers. If you have questions about participating in a clinical trial, contact AFTD’s HelpLine at 1-866-507-7222 or info@theaftd.org.