Company: GHRS
Filing Date: 2025-02-27
Form Type: 20-F
Source: 0001140361-25-006175
Chunk: 32

Company: GH Research PLC
Filing Date: 2025-02-27
Form: 20-F
Item: Item 4
Chunk 32
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 and an intravenous toxicology study in non-human primates. The results of these studies, together with the data from published academic literature, supported the initiation of our Phase 2a clinical trials of GH001 in BDII and a current major depressive episode (GH001-BD-202) and PPD (GH001-PPD-203), our Phase 2b clinical trial of GH001 in TRD (GH001-TRD-201), our Phase 1 clinical pharmacology trial of with our proprietary device (GH001-HV-106), and our Phase 1 clinical trial of GH002 in healthy volunteers (GH002-HV-105).
 
On November 9, 2023, we announced that our IND for GH001 administered using our proprietary aerosol delivery device was placed on clinical hold by the FDA, with the FDA requesting that we provide additional information, including (i) an inhalation toxicology study in a non-rodent species and an additional inhalation toxicology study in rats, (ii) additional device design verification information and (iii) updates to our investigator brochure, to resolve the hold.
 
On January 10, 2025, we announced that (i) the requested inhalation toxicology study in a non-rodent species had been completed, and the pathology report concluded that there were no histology findings in the respiratory tract of any dogs at any dose level evaluated in the study and (ii) the requested additional inhalation toxicology study in rats had been completed which showed histology findings consistent with our previously completed study in rats.
 
Further nonclinical studies are ongoing or expected to be performed in GH001 and/or other product candidates as our development progresses.
 
Delivery Systems and Routes of Administration for Mebufotenin
 
We are working to optimize current delivery systems and to investigate additional delivery systems and additional routes of administration for mebufotenin which we believe could expand the patient population that could benefit from our product candidates.
  Table of Contents
Currently, GH001, our inhalable mebufotenin product candidate, has been vaporized using an inhalation device purchased from a third party, which is a CE-marked medical device in the EU and licensed as a medical device in Canada and Australia. We continue to use that device in our Phase 2b trial in TRD patients (GH001-TRD-201) and in the recently initiated Phase 2a trials in bipolar II disorder (GH001-BD-202) and postpartum depression (