Coya High-Dose Interleukin-2 Misses The Mark In Mid-Stage Alzheimer's Study

 On Tuesday, Coya Therapeutics, Inc. (NASDAQ: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.

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. This demonstrated a clinically meaningful difference of 4.93 points (P=0.061).

• This cognitive effect was not observed in the LD IL-2 q2wks administration, demonstrating a similar decline as placebo.

• Stabilization of ADCS-CGIC (Alzheimer’s Disease Assessment Scale – Cognitive Subscale) scores was observed in both the IL-2 q4wks and IL-2 q2wks groups on day 148 compared to the placebo arm, which declined from baseline.

• The change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) on Day 148 was 1.401 in the LD IL-2 q4wks group, 1.976 in the LD IL-2 q2wks group, and 1.893 in the placebo group, suggesting a 27% slower decline in CDR-SOB scores following LD IL-2 q4wks treatment compared to the placebo group.

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