SEC Form 8-K filed by Coya Therapeutics Inc.
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| Item 8.01 | Other Events. |
On January 8, 2026, Coya Therapeutics, Inc. (the “Company”) issued a press release announcing positive results of an investigator-initiated proof of concept open-label study with low-dose IL-2 and CTLA4-Ig combination treatment in 9 patients with Frontotemporal Dementia (FTD) over a 6 month period. The study was led by Dr. Alireza Faridar and Dr. Stanley Appel at the Houston Methodist Neurological Institute (Houston, TX) with funding from The Peggy and Gary Edwards Endowment Fund. Study patients received subcutaneously administered CTLA4-Ig, along with a 5-day course of low-dose IL-2 every four weeks, for a total of 22 weeks of dosing and follow-up. The study enrolled 9 patients, and data demonstrated enhanced Treg numbers and function and cognitive function stability as measured by CDR-FTLD and Montreal Cognitive Assessment (MOCA).
Study Results
Safety and feasibility
Nine individuals clinically diagnosed with FTD were enrolled into this study. The primary endpoints were the incidence and severity of adverse events. The most common adverse event was erythema at the injection site (33.3% of individuals), which was mild and recovered spontaneously. No serious adverse events were observed during the study.
Treg Suppression
Treg suppressive function was significantly increased starting as early as 2 weeks after dosing and remained significantly amplified throughout the 22-week treatment period.
Treg Percentage followed a similar pattern as Treg suppressive function, with significant separation from baseline occurring as early as 2 weeks post dosing and remained significantly elevated through week 22.
CD25 mean fluorescence intensity (MFI) was significantly increased as early as 2 weeks after dosing and remained significantly elevated through 22 weeks.
FOXP3 MFI was significantly increased as early as 2 weeks after dosing.
Cognitive Measures
MOCA (Montreal Cognitive Assessment) scores remained unchanged at week 22, compared to baseline (Baseline, 13.5 and week 22, 14) suggesting no decline in cognitive function over the 22-week period.
CDR-FTLD scores did not significantly change at week 22 compared to baseline levels (Baseline, 4.8 and week 22, 5.5), suggesting no decline in cognitive and functional status of the enrolled individuals over the 22-week treatment period.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| COYA THERAPEUTICS, INC. | ||||||
| Date: January 8, 2026 | By: | /s/ Arun Swaminathan Ph.D. | ||||
| Arun Swaminathan Ph.D. Chief Executive Officer | ||||||