Company: GHRS
Filing Date: 2025-02-27
Form Type: 20-F
Source: 0001140361-25-006175
Chunk: 27

Company: GH Research PLC
Filing Date: 2025-02-27
Form: 20-F
Item: Item 4
Chunk 27
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ent adverse event; MedDRA = Medical dictionary for regulatory activities; PT = Preferred term;
 
Results: Efficacy
 
The primary endpoint of the trial was met with a significant reduction from baseline of -15.2 points in Montgomery-Åsberg Depression Rating Scale (MADRS) total score on Day 8 after administration of GH001, compared with +0.3 points in the placebo group (difference of -15.5 points, p<0.0001).
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All secondary endpoints in the trial were met, with results consistent with the primary endpoint. The majority of the patients treated with GH001 achieved remission (MADRS≤10) and were responders (MADRS reduction ≥50%) at 2 hours, Day 2 and Day 8. Remission and response rates with GH001 were significantly greater than placebo at all timepoints (p<0.0001). Treatment with GH001 led to clinically and statistically significant improvements on the Clinical Global Impression Severity,  or CGI-S, and Hamilton Anxiety Rating, or HAM-A, scales, and the Quality of Life Enjoyment and Satisfaction Questionnaire, or Q-LES-Q-SF Questionnaire, on Day 8, compared with placebo.
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As of January 22, 2025, 9 patients are ongoing in the trial, while 54 patients have completed the full 6-month follow-up of the OLE and 18 patients discontinued, with one patient’s discontinuation due to an adverse event.
 
Of the 54 patients who completed the OLE as of January 22, 2025:
 

•   77.8% of patients were in remission (MADRS≤10) at the 6 month visit and 81.5% were responders (MADRS reduction ≥50%);
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•   Mean MADRS total score at 6 months was 8.6;
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•   63.0% (n=34) received 1-4 treatments with GH001;
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