Company: GHRS
Filing Date: 2025-02-27
Form Type: 20-F
Source: 0001140361-25-006175
Chunk: 22

Company: GH Research PLC
Filing Date: 2025-02-27
Form: 20-F
Item: Item 4
Chunk 22
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ation of GH001 was well tolerated across the three trials with no severe or serious adverse events reported and with treatment emergent adverse events, or TEAEs, observed in 64.1% of subjects. The majority of TEAEs were mild in severity. No noteworthy changes in vital signs were observed; transient increases in heart rate and blood pressure shortly after GH001 administration were not considered clinically significant. Safety assessments, including laboratory analyses, psychiatric scales, electrocardiogram, and cognitive function tests showed no clinically meaningful changes. The most common TEAEs reported were: headache, anxiety, nausea and fatigue.
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Phase 1 Results: Efficacy (GH001-TRD-102)
 
As a secondary objective in Part A, we evaluated clinical activity, including MADRS remission, defined as a MADRS total score of less than or equal to 10, and MADRS clinical response, defined as a reduction of 50% or more from baseline in the MADRS total score. Two of four patients (50%) in the 12 mg group and one of four patients (25%) in the 18 mg group of Part A had a MADRS remission on Day 8, as well as a MADRS clinical response, and one further patient (25%) in the 18 mg group had a MADRS clinical response on Day 8. Of the three patients in remission on Day 8, all were in remission beginning on Day 2, with two in remission as early as two hours after dosing. The mean MADRS change from baseline at day seven was -21.0 (-65%) in the 12 mg group and -12.5 (-40%) in the 18 mg group.
 
The primary endpoint of Part B was defined as the proportion of patients in remission on day seven after dosing, defined as a MADRS total score of less than or equal to 10. This primary endpoint was met with seven of eight patients (87.5%) achieving a MADRS remission on Day 8 (p<0.0001). Of those seven patients, all were in remission beginning on Day 2, with four in remission as early as two hours after dosing. All seven patients with a remission on Day 8 also achieved a MADRS clinical response, defined as a reduction of 50% or more from baseline in the MADRS total score