Houston, TX, June 8, 2023 - (ACN Newswire) - Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing multiple therapeutic programs intended to enhance Treg function, including biologics, today reported additional biomarker and brain imaging results from an open-label proof-of-concept clinical study for COYA 301 in patients with mild to moderate AD. Results of the study will be presented June 7th, 2023, at the LD Micro Conference in Los Angeles, CA. The clinical study data can be viewed here.Highlights:
- Coya reports new data illustrating that administration of COYA 301 (low dose Interleukin-2 (IL-2)) in an open- label study in 8 patients with mild to moderate AD (COYA 301 Trial) resulted in a statistically significant reduction in the expression of three well characterized proinflammatory cytokines -- Tumor Necrosis Factor alpha (TNF-a), Interleukin 6 (IL-6), and Interleukin 1- Beta (IL-1ß) -- which correlated with lack of cognitive decline of the patients over the course of the study.
- TNF-a is one of the main inflammatory cytokines involved in initiating and propagating an inflammatory response and its role in the pathophysiology of AD has been documented. The proinflammatory cytokines IL-6 and IL-1ß have also been documented to play a central role in AD and in the development of neuroinflammation and induction of neuronal damage.
- Furthermore, Coya reports a case study of a patient in the COYA 301 trial who had pre-treatment and post-treatment Positron Emission Tomography (PET) brain scans to evaluate neuroinflammation. Meaningful reductions in neuroinflammation were observed throughout the cerebral cortex including hippocampal regions following treatment with COYA 301, which correlated with improvement in cognitive function in this patient.
- Coya previously reported that patients in the COYA 301 trial achieved a statistically significant improvement in cognitive function, as measured by the Mini-Mental State Examination test (MMSE) and no cognitive decline when measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), and the Clinical Dementia Rating-Sum of Boxes scale (CDR-SB).
- Coya also previously reported that treatment with COYA 301 restored peripheral Treg function and numbers, significantly lowered the levels of systemic chemokines CCL11, CCL2, and cytokine IL-15, and was well tolerated.
- An ongoing academic phase 2 double blind randomized trial (supported by the Gates Foundation and Alzheimer's Association) for use of low dose IL-2 in up to 46 mild to moderate AD patients that is underway at Houston Methodist (led by Alireza Faridar M.D. and the Chair of Coya's SAB, Stanley Appel, M.D.), should report top line data in Q2 2024, and inform Coya on its strategy.
The open-label study enrolled 8 patients with confirmed presence of brain amyloid pathology and baseline MMSE scores between 12 and 25. The patients were treated with five day-courses of COYA 301 for four monthly cycles and were followed for two months post-treatment. Treg function and numbers, serum biomarkers of inflammation, and cognitive functioning as measured by the ADAS-Cog, CDR-SB and MMSE assessment tools were evaluated.
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