Coya Therapeutics (COYA), a clinical-stage biotechnology company, has released additional proof-of-concept clinical biomarker data for their treatment of Alzheimer’s disease (AD). The results, presented at the Alzheimer’s Association International Conference, show promising outcomes in patients treated with Coya’s ld IL-2 therapy.
The study enrolled eight patients with confirmed brain amyloid pathology and baseline MMSE scores between 12 and 25. These patients received subcutaneous ld IL-2 treatment over four monthly cycles, with follow-up conducted for two months after the treatment. The study evaluated Treg function and numbers, serum biomarkers of inflammation, safety and tolerability, and cognitive functioning using assessment tools such as ADAS-Cog, CDR-SB, and MMSE.
The recent data revealed a significant decrease in the blood levels of proinflammatory cytokines and chemokines (CCL4, FLT3LG, and TNFα) in patients with AD who received ld IL-2 treatment. These findings build upon the positive results previously announced by Coya in May 2023.
Previous reports showed that ld IL-2 treatment was successful in expanding Treg populations and enhancing their function. The percentage of Tregs nearly doubled after treatment, and Treg suppressive function significantly increased as well. Furthermore, cognitive function, as measured by the MMSE scores, showed a statistically significant improvement during the treatment phase.
It is important to note that the study found no significant changes in cognitive decline as measured by the ADAS-Cog and CDR-SB scales, indicating the potential of ld IL-2 therapy in maintaining cognitive function.
The administration of ld IL-2 was deemed safe and well-tolerated, with only mild injection-site reactions and leukopenia reported as adverse events. No serious adverse events occurred, and no patient discontinued the study.
Following the positive outcomes of the proof-of-concept study, Coya Therapeutics plans to conduct a Phase 2 double-blind, placebo-controlled study. This study will involve approximately 46 patients with mild-to-moderate AD and will evaluate the safety, tolerability, Treg function, blood biomarkers of neuroinflammation, and efficacy of two dose regimens of ld IL-2 compared to a placebo. The study is expected to provide top-line results in July 2024 and is funded by the Gates Foundation and the Alzheimer’s Association.
Stanley Appel, M.D., Professor at Houston Methodist and Chair of Coya’s Scientific Advisory Board, expressed optimism about the potential of ld IL-2 treatment for AD patients. He commented, Our research studies documenting a significant reduction of Treg neuroprotective functions in AD led to our use of low dose IL-2 to enhance Treg numbers and suppressive functions. Our 8 patient study in AD was safe and well-tolerated, decreased pro-inflammatory signaling, and suggested a beneficial clinical effect. We are optimistic that this approach may help address the unmet needs of our deserving AD patients.
Coya Therapeutics is dedicated to advancing therapeutic platforms aimed at enhancing Treg function. Their ld IL-2 treatment shows promise in reducing inflammation, improving cognitive function, and potentially addressing the unmet needs of patients with Alzheimer’s disease.
