---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-131084"
form_type: "8-K"
ticker: "GANX"
cik: "0001819411"
company_name: "Gain Therapeutics, Inc."
filed_at: "2024-12-23T23:59:59+00:00"
generated_at: "2026-05-28T23:46:31.473864+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Gain Therapeutics receives Australian approval to start Phase 1b trial of GT-02287 for Parkinson's disease

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-24-131084
- form_type: 8-K
- ticker: GANX
- cik: 0001819411
- company_name: Gain Therapeutics, Inc.
- filed_at: 2024-12-23T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1819411/000110465924131084/0001104659-24-131084-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1819411/000110465924131084/tm2431811d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-131084
- JSON: https://secwatch.observer/filing/0001104659-24-131084.json
- Plain text: https://secwatch.observer/filing/0001104659-24-131084.txt

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