Clinical TrialMay 21, 2026, 07:02 AM
GH Research GH001 Shows Rapid, Sustained Efficacy in TRD Phase 2b Trial
AI Summary
GH Research PLC presented positive Phase 2b clinical trial results for its investigational drug GH001 in treatment-resistant depression (TRD) at the ASCP Annual Meeting. The data showed GH001 achieved rapid and sustained improvements in anhedonia, significantly reducing MADRS anhedonia factor scores by -9.9 points versus placebo at Day 8. Importantly, GH001's efficacy was independent of prior antidepressant treatment failures, maintaining consistent remission rates of 54-64% at Day 8 across subgroups. The trial also demonstrated significant improvements in overall illness severity, anxiety, and quality of life, with these beneficial effects sustained through a 6-month open-label extension.
Key Highlights
- GH001 reduced MADRS anhedonia factor by -9.9 points vs placebo at Day 8 (P<0.0001).
- Remission rates for GH001 were 54-64% at Day 8, independent of prior treatment failures.
- GH001 improved Clinical Global Impression-Severity (CGI-S) by -2.5 points vs placebo (P<0.0001).
- Hamilton Anxiety Rating Scale (HAM-A) scores improved by -10.0 points vs placebo (P<0.0001).
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) improved by 21.4 points vs placebo (P<0.0001).
- Improvements in anhedonia, severity, anxiety, and quality of life were sustained at Month 6 in OLE completers.
Price Impact
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