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On Thursday, Coya Therapeutics, Inc. (NASDAQ:COYA) announced blood biomarker data from an investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of LD IL-2 in patients with Alzheimer’s disease (AD).
Statistically significant reduced levels of proinflammatory markers were observed in patients receiving a five-day treatment of subcutaneous LD IL-2 on a monthly cycle in comparison to a biweekly 5-day administration or placebo.
Also Read: EXCLUSIVE: Coya Therapeutics Expands Its Pipeline With Combo Therapy For Inflammatory Diseases
Lower blood levels of the proinflammatory chemokine (C-C motif) ligand 2 (CCL2) (p<0.05) and proinflammatory cytokine IL-15 (p <0.001) were statistically significant. A statistically significant increase in the anti-inflammatory cytokine IL-4 (p<0.01) in patients receiving monthly cycles of LD IL-2 was observed compared to patients receiving a placebo.
When treatment was removed at the end of the five-month treatment period, the anti-inflammatory benefits reverted back to placebo levels.
In addition, patients receiving LD IL-2 cycles at the higher biweekly frequency showed a smaller impact on these factors than monthly LD IL-2.
Monthly LD IL-2 showed an increase in Aβ42 levels in cerebrospinal fluid (CSF), suggesting increased clearance of amyloid-β, stable levels of neurofilament light chain (NfL) in CSF, and statistically significant Treg expansion, all demonstrating targeted biological activity.
In addition, patients receiving monthly LD IL-2 showed a 4.93-point improvement in the ADAS-Cog score (Alzheimer’s cognitive scale) compared to placebo over the 21-week treatment period.
LD IL-2 was well-tolerated and no serious adverse events (SAEs) or deaths were reported. The most common AEs were mild injection site reactions and a mild increase in eosinophil counts.
In October, Coya Therapeutics released results from the placebo-controlled Phase 2 trial of LD IL-2 in patients with mild to moderate Alzheimer's Disease.
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.
Price Action: COYA stock is up 9.48% at $7.15 at last check Thursday.
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