secwatch.observer — SEC 8-K summary
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Issuer:     Gain Therapeutics, Inc. (GANX)
CIK:        0001819411
Form:       8-K
Filed at:   2024-12-23T23:59:59+00:00
Accession:  0001104659-24-131084
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Gain Therapeutics receives Australian approval to start Phase 1b trial of GT-02287 for Parkinson's disease
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- Australian ethics approval obtained for Phase 1b trial of GT-02287 in GBA1-PD and idiopathic PD patients.
- Trial will dose 13.5 mg/kg/day for three months; primary endpoint safety/tolerability; secondary endpoints include biomarkers.
- Enrollment expected to complete spring 2025; data anticipated mid-2025.
- Phase 1 in healthy volunteers showed safety, CNS exposure, and >50% increase in GCase activity (statistically significant).
- Company plans Phase 2 preparation after Phase 1b results.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1819411/000110465924131084/0001104659-24-131084-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1819411/000110465924131084/tm2431811d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-131084

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