On Tuesday, Coya Therapeutics, Inc. COYA released results from the placebo-controlled Phase 2 trial of LD IL-2 in patients with mild to moderate Alzheimer’s Disease. The data was shared at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24).
The study met its primary and secondary endpoints, demonstrating that treatment with low-dose interleukin-2 is safe and well-tolerated in patients with Alzheimer’s. Also Read: EXCLUSIVE: Coya Therapeutics, Focused On Neurodegenerative Diseases Has Gained 70% Since IPO; CEO Highlights Efforts On Combination Therapy For Rare Diseases LD IL-2 showed targeted biological activity. Additionally, the q4wks regimen led to significant improvements (defined by increased levels) in cerebrospinal fluid (CSF) soluble Aβ42 levels, an indicator of amyloid pathology.
However, the company said that the q2wks group, representing the higher total dose cohort, did not exhibit benefits in exploratory endpoints. LD IL-2 q2wks dosing also resulted in a reduction of Foxp3 expression, a critical marker of Treg functionality (a lower level or loss of Foxp3 expression is associated with unstable/dysfunctional Tregs). The company will likely advance LD IL-2 q4wks.
The analyses of exploratory endpoints also showed: The Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog14, cognitive function) scores on day 148 showed a slight improvement following LD IL-2 q4wks administration vs. placebo, which worsened by 4.480 from baseline.
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