Slide 1: A Phase 1/2 Trial of GH001 in Patients with Treatment-Resistant Depression
A Phase 1/2 Trial of GH001, a Vaporized 5 - Methoxy - N,N - Dimethyltryptamine Formulation, in Patients with Treatment - Resistant Depression (TRD) 1 Clinicaltrials.gov ID NCT04698603 Johannes Reckweg 1 , Cees van Leeuwen 1 , Cécile Henquet 2 , Thérèse van Amelsvoort 2 , Natasha Mason 1 , Riccardo P
Slide 2: Disclosures
Grants The study was funded by GH Research Advisory Board/Consultant Johannes Reckweg and Jan Ramaekers work as consultants for GH Research 2 Disclosures GH001 - TRD - 102 ECNP 2022 – Poster P.0450
Slide 3: The Problem for Patients with Depression
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 2 4 6 8 10 12 14 Cumulative Remission Rate (% Patients) Week ... Remission Rates in TRD < 15% Established Therapies are Slow - Acting 37% 31% 14% 13% 56% 62% 67% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 1 2
Slide 4: 5-MeO-DMT and GH001
• 5 - MeO - DMT (5 - Methoxy - N,N - Dimethyltryptamine) • Naturally - occurring psychoactive substance from tryptamine class • Highly potent agonist on 5 - HT1A and 5 - HT2A receptors • Psychoactive effects with ultra - rapid onset (within seconds) and short duration (5 to 30 min) • High propensity
Slide 5: Phase 1/2 Trial in TRD (GH001-TRD-102, n=16)
Key Assessments MADRS 2 - hrs PE Scale Safety MADRS 1 - day Cognitive function Safety MADRS 7 - day Cognitive function Safety GH001 Administration Day 1 Day 7 Phase 1/2 Trial in TRD (GH001 - TRD - 102, n=16) 5 PE, Peak Experience; MADRS, Montgomery - Åsberg Depression Rating Scale; IDR, Individualiz
Slide 6: Phase 2 (IDR) – Efficacy (MADRS)
Phase 2 (IDR) – Efficacy (MADRS) 6 PE, Peak Experience; MADRS, Montgomery - Åsberg Depression Rating Scale; MADRS remission, MADRS of ≤10; MADRS response, Reduction of ≥50% from baseline in MADRS; S, Screening; D0 - B, Day 0 Baseline; D0 - H2, Day 0 2 hours; D1, Day 1; D7, Day 7. • Primary endpoint
Slide 7: Phase 1 (Single Dose) and Phase 2 (IDR) – Safety
Phase 1 (Single Dose) and Phase 2 (IDR) – Safety 7 ADR, Adverse Drug Reaction, an adverse event with a relationship code to the investigational product of definite, probable, o r p ossible, or where code is missing IDR, Individualized Dosing Regimen; C - SSRS, Columbia - Suicide Severity Rating Scal
Slide 8: Conclusions
8 • GH001 was well tolerated, and no serious adverse events were reported • No clinically significant changes in vital signs, cognitive function, psychiatric safety assessment • GH001 allows rapid and individualized dosing optimization • A single dosing day with GH001 IDR achieved a rapid (within 24