secwatch.observer — SEC 8-K summary
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Issuer:     Coya Therapeutics, Inc. (COYA)
CIK:        0001835022
Form:       8-K
Filed at:   2023-03-21T23:59:59+00:00
Accession:  0001193125-23-075260
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Coya reports positive proof-of-concept data for COYA 302 in ALS; Treg function up, biomarkers down, ALSFRS stable
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- Treatment with IL-2/CTLA4-Ig (COYA 302) over 48 weeks significantly increased Treg suppressive function and Treg numbers in 4 ALS patients.
- Biomarkers of oxidative stress (4-HNE, ox-LDL) were reduced; mean ALSFRS-R scores not statistically different from baseline, suggesting disease stabilization.
- Adverse events limited to mild injection site reactions; no deaths or serious AEs; all 4 patients completed the study.
- Study is open-label, single-arm, proof-of-concept; data supports further development of COYA 302 for ALS.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1835022/000119312523075260/0001193125-23-075260-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1835022/000119312523075260/d464304d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-075260

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer