Company: GHRS
Filing Date: 2025-02-27
Form Type: 20-F
Source: 0001140361-25-006175
Chunk: 28

Company: GH Research PLC
Filing Date: 2025-02-27
Form: 20-F
Item: Item 4
Chunk 28
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 91.7% of patients who had remission at Day 8, also had remission at 6 months (patients who completed the 6-month OLE follow-up per protocol: patients who terminated early are excluded; N=53 patients in total; 1 OLE completer not
                                                                                      evaluable due to missing data at data cut of January 22, 2025).                                                                                   
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Safety analysis has not yet been completed for the OLE as it remains ongoing, but as of January 22, 2025, no serious adverse events have been reported throughout the OLE.
 
Our Phase 2b clinical trial of GH001 in patients with TRD is subject to certain risks and uncertainties, as is the case with our other clinical trials. See “Item 3. Key Information – D. Risk Factors”.
 
Phase 1: Clinical Trial with GH001 aerosol delivery device in healthy subjects (GH001-HV-106, NCT06511947)
 
We are also currently recruiting an open-label Phase 1 trial to determine the pharmacokinetic, pharmacodynamics, and safety of GH001 administered via a proprietary aerosol delivery device in healthy subjects.
 
Trial Design
 
This is an open-label, Phase 1 clinical trial in healthy subjects that will include single- and multiple-dose parts. Following a screening period of up to 4 weeks prior to baseline, one single dose (Part 1), an IDR (Part 2), or two single doses (Part 3) of GH001 will be administered. In Part 1 and Part 2, GH001 will be administered via a proprietary aerosol delivery device on Day 1.
 
In Part 2, the IDR consists of up to three increasing doses of GH001 given at approximately 1-hour intervals.
 
The primary endpoint of this trial is to assess the pharmacokinetic profile of mebufotenin and bufotenine, a metabolite of mebufotenin, and safety and tolerability. Participants are monitored on the dosing day, with additional follow-up visits on Day 8 and Day 31.
 
Regulatory Interactions
 
 Following a type C meeting with the FDA in May 2023,