---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-391378"
form_type: "8-K"
ticker: "COYA"
cik: "0001835022"
company_name: "Coya Therapeutics, Inc."
filed_at: "2026-09-15T12:15:06+00:00"
generated_at: "2026-09-15T12:20:26.048113+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Coya Therapeutics hits 100th patient enrollment in Phase 2/3 ALSTARS trial for COYA 302 in ALS

## Summary
- 100th patient enrolled in Phase 2/3 ALSTARS trial (NCT07161999) evaluating COYA 302 for ALS as of Sept 15, 2026.
- Trial targets 120 total participants; enrollment trending to complete in time for topline data in early Q2 2027.
- Study is randomized, double-blind, placebo-controlled, 1:1:1 dosing: two COYA 302 regimens vs placebo over 24 weeks, then 24-week active extension.
- Primary endpoint: change in ALSFRS-R total score from baseline to Week 24 vs placebo; also evaluates safety, biomarkers.
- COYA 302 combines proprietary low-dose IL-2 and CTLA-4 Ig; FDA Fast Track designation previously granted.

## SEC filing metadata
- accession: 0001193125-26-391378
- form_type: 8-K
- ticker: COYA
- cik: 0001835022
- company_name: Coya Therapeutics, Inc.
- filed_at: 2026-09-15T12:15:06+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1835022/000119312526391378/0001193125-26-391378-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1835022/000119312526391378/d896544d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-391378
- JSON: https://secwatch.observer/filing/0001193125-26-391378.json
- Plain text: https://secwatch.observer/filing/0001193125-26-391378.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.