Gh Research Plc · NASDAQ:GHRS
Gh Research — 37th ECNP Congress (September 2024)
10 slides from Gh Research's conference presentation, Sep 20, 2024
Slide 1: Review of Ongoing Phase 2b Treatment-Resistant Depression Clinical Trial (GH001-TRD-201)
19/09/2024 1 Review of Ongoing Phase 2b Treatment-Resistant Depression Clinical Trial (GH001-TRD-201) Wiesław J. Cubała Medical University of Gdańsk
Slide 2: Author Disclosure
Author Disclosure 19/09/2024 2 Conflict of interest statement regarding my presentation in the ‘Industry session financially supported by GH Research during the 37th ECNP congress.’ Review of Ongoing Phase 2b TRD Clinical Trial (GH001-TRD-201) on 22 September 2024. I have an interest in relation to
Slide 3: Overview of GH001 Clinical Trial Aspects
19/09/2024 3 A synthetic formulation of the serotonergic psychedelic mebufotenina,b administered via pulmonary inhalation Rapid onset (within seconds) and short duration (<30mins) of psychoactive effects Single-dose administration OR an individualized dosing regimen (IDR) with up to three escalating
Slide 4: Development Program Status
19/09/2024 4 Two Phase 1 trials in HV (GH001-HV-101, GH001-HV-103) One Phase 1/2 trial in patients with TRD (GH001-TRD-102) 78 subjects dosed to date (completed studies only; 62 HV, 16 TRD) Three completed trials Four ongoing trials Phase 1 trial in HV (GH001-HV-106-2) using GH Research’s proprietar
Slide 5: Utilization of IDR Dose Escalations to Maximize Therapeutic Response
GH001 Single Dose: Inter-Person Variability GH001 IDR:Maximization of Ultra-Rapid and Durable Remissions MADRS score MADRS score MADRS score MADRS score Dose 1 Dose 1 Dose 2 Dose 3 Dose 2 Dose 1 No remission Remissiona Remissiona Remissiona Remissiona Hypothetical Patient 1 Hypothetical Patient 2 Hy
Slide 6: Safety and Tolerability of GH001 in Completed Trials
20/09/2024 6 Safety and Tolerability of GH001 in Completed TrialsGH001-HV-1011, GH001-HV-1032, and GH001-TRD-1023 Safety Parameters, n Overall Population N=78 Any TEAE, n 50 Headache, no. of events 19 Anxiety, no. of events 12 Nausea, no. of events 8 Fatigue, no. of events 7 Any Serious AE 0 Any AE
Slide 7: Efficacy of GH001 GH001-TRD-102
19/09/2024 7 Single Dose (Day 7) Individualized Dosing Regimen (Day 7) 2/4 (50%) patients in the 12 mg group and 1/4 (25%) in the 18 mg group had a MADRS remission at Day 7 2/8 patients had a PEc and both had a MADRS remission at Day 7 7/8 (87.5%) patients had a MADRS remission at Day 7 7/8 patients
Slide 8: Efficacy of GH001 (MADRS Change from Baseline)
Hour 2 Day 1 Day 7 GH001 p=0.0018 p<0.0001 p<0.0001 Baselinea 19/09/2024 8 Efficacy of GH001 (MADRS Change from Baseline) GH001-TRD-102: Individualized Dosing Regimen1 Abbreviations: MADRS = Montgomery–Åsberg Depression Rating Scale. a Baseline mean MADRS = 32. 1. Reckweg JT, et al. Front. Psychiatr
Slide 9: GH001-TRD-201 Trial Design
19/09/2024 9 Abbreviations: D = Day; H = Hour; IDR = Individualized dosing regimen; M = Month; MADRS = Montgomery–Åsberg Depression Rating Scale; OLE = Open-label extension; PRN = Pro re nata (as needed); TRD = Treatment-resistant depression. aThe double-blind phase was a fixed duration of 7 days (±
Slide 10: Thank you for your attention!
Thank you for your attention! 19/09/2024 10