Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 171

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 171
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 Placebo Results: Safety GH001 was well tolerated and no serious adverse events were reported in the double-blind part of the trial.

| • | All TEAEs were mild or moderate with no severe adverse events observed. |

| • | The most common TEAEs in patients treated with GH001 were nausea, salivary hypersecretion, paresthesia, headache, and dysgeusia. There were no TEAEs of flashbacks reported. |

| • | No clinically significant changes were observed in any of the safety laboratory analyses or vital parameters, including heart rate, blood pressure and ECG, and there were no adverse events related to 
 vital signs.                                                                                                                                                                                            |

| • | There were no TEAEs leading to study drug withdrawal or early withdrawal from the double-blind part of the trial. |

| • | No dissociative state symptoms or sedation were observed at discharge after treatment with GH001 and 97.4% of patients were discharge ready within 1 hour of the last dose. Patients were not required 
 to observe any post-discharge restrictions.                                                                                                                                                            |

| • | No evidence of treatment-emergent suicidal ideation or behavior or treatment-emergent BPRS+ symptomswere observed after treatment with GH001. |

98 Table of Contents 1TEAE=AE that emerges after the start of study drug dosing having been absent pretreatment, or an AE that worsens in severity relative to a pretreatment onset 2Number of events for mild, moderate and severe TEAEs represents total number of events of each severity 3Treatment-related TEAE/SAE is any TEAE/SAE that is possibly or probably related to the study drug 4SAE=any untoward medical occurrence of effect at any dose that a) results in death, b) is life threatening, c) requires inpatient hospitalization or prolongation of hospitalization, d) results in persistent or significant disability or incapacity, e) is a congenital anomaly or birth defect, f) any other important medical event Abbreviations: AESI = Adverse event of special interest; Pts = Patients; SAE = Serious adverse event; TEAE = Treatment-emergent 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