Slide 1: Long-Term Data for GH001 in Patients with Treatment-Resistant Depression
Long-Term Data for GH001 in Patients with Treatment-Resistant Depression Wiesław J. Cubała, MD, PhD Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland Co-authors: Malek Bajbouj, Bernhard T. Baune, Narcís Cardoner, Fabian Devlin, Rosa Maria Dueñas Herrero, Mat
Slide 2: Author Disclosures (1 of 2)
Author Disclosures Wiesław J. Cubała Grants – Acadia, Angelini, Beckley Psytech, Compass Pathways, GH Research, HMNC Brain Health, Intra-Cellular Therapies, Janssen, MSD, MindMed, Neumora, Novartis, Otsuka, Recognify Life Sciences. Honoraria – Angelini, GH Research, Janssen, and Novartis. Advisory b
Slide 3: Author Disclosures (2 of 2)
Author Disclosures Shane J. McInerney Principal investigator – GH Research and Transcend Therapeutics. Honoraria – Janssen and Lundbeck. Alexander Nawka Principal investigator – GH Research. Tomáš Páleníček Principal investigator – Compass, GH Research, MAPS, and Ketabon. Shares – Psychedelická klin
Slide 4: Background: TRD and GH001
TRD remains one of the most pressing challenges in psychiatry affecting approximately 30% of patients treated for MDD1 Current therapies for TRD are limited, and there is a large unmet need for treatments that are well tolerated and offer rapid therapeutic benefit and long-term remission Mebufotenin
Slide 5: Trial Schematic and Re-treatment Criteria
For re-treatment (up to five GH001 IDRsa), the patient must have met one of the following criteria: MADRS score >18 MADRS score >10 and ≤18 and MADRS score ≤10 not observed at Day 8 of the prior treatment or at any visit since MADRS score >10 and ≤18 and MADRS score >18 observed since the most recen
Slide 6: Eligibility Criteria
6 Eligibility Criteria aCurrent MDE confirmed by the Mini-International Neuropsychiatric Interview. Abbreviations: DSM-5 = Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; HAM-D-17 = 17-Item Hamilton Depression Rating Scale; MDD = Major depressive disorder; MDE = Major depressiv
Slide 7: Baseline Characteristics and Patient Disposition
7 Baseline Characteristics and Patient Disposition aGH001 was administered as a monotherapy and patients who started additional antidepressant treatment were discontinued from the trial. Abbreviations: BMI = Body mass index; HAM-D-17 = 17-Item Hamilton Depression Rating Scale; MADRS = Montgomery-Åsb
Slide 8: Primary Endpoint: MADRS Reduction at Day 8 vs Placebo
LS mean difference vs placebo: −15.5 (P<0.0001) Effect size: Cohen’s d = −2.0 LS Mean (±SE) Change From Baseline in MADRS Total Score BL 2H Day 2 Day 8 Primary Endpoint: GH001 Led to −15.5 Mean MADRS Reduction From Baseline on Day 8a Compared with Placebo in the Double-Blind Period aFDA Guidance not
Slide 9: Response and Remission Rates at Day 8
****P<0.0001 Response: ≥50% reduction from baseline in MADRS total score | Remission: MADRS total score ≤10 GH001 Placebo **** **** Remission NNT=2 GH001 Led to 60.0% Response Rate and 57.5% Remission Rate at Day 8 vs 0% With Placebo in the Double-Blind Period Abbreviations: MADRS = Montgomery-Åsber
Slide 10: MADRS Reduction Reproduced in Placebo Group in OLE
10 Reduction in MADRS With GH001 in Double-Blind Part Reproduced in Placebo Group With First Active GH001 Treatment in the OLE Abbreviations: BL = Baseline; D = Day; H = Hour; MADRS = Montgomery-Åsberg Depression Rating Scale; SE = Standard error. Double-Blind Patients who received GH001 (n=40) Open
Slide 11: 73% Remission Rate at 6 Months in OLE Completers
11 There was a 73% Remission Rate at 6 Months in OLE Completers aIncludes 63 patients who completed the 6-month OLE per protocol (18 patients terminated early are excluded). bApproximately 6 months post-study start (median 168 days from Day 1 of double-blind part). cRemission defined as MADRS total
Slide 12: Remission Rate at 6 Months in OLE Completers
12 Remission Rate at 6 Monthsa in OLE Completersb a‘6 Months’ or ‘Month 6’ (end of trial) was at approximately 6 months post-study start (mean 168 days from Day 1 of double-blind part). bIncludes 63 patients who completed the 6-month OLE per protocol (18 patients terminated early are excluded). cRem
Slide 13: Overview of Adverse Events in the Open-Label Extension
13 Overview of Adverse Events in the Open-Label Extension aTEAEs were classified according to the Medical Dictionary of Regulatory Activities (MedDRA) Version 26.0. Abbreviations: AESI = Adverse event of special interest; TEAE = Treatment-emergent adverse event; TRD = Treatment-resistant depression.
Slide 14: GH001 Well Tolerated in Patients with TRD up to 6 Months
14 GH001 Administration was Well Tolerated in Patients with TRD up to 6 Months aTwo severe treatment-related TEAEs were reported in the OLE; affect lability occurred shortly after administration of GH001 and resolved within 4 minutes and one event of migraine, considered a serious TEAE not related t
Slide 15: Adverse Events of Special Interest in the OLE
15 Adverse Events of Special Interest in the Open-Label Extension Abbreviations: AESI = Adverse event of special interest; TEAE = Treatment-emergent adverse event. Patients, n (%) GH001 (n=81) Any treatment-emergent AESI 30 (37.0) Anxiety 9 (11.1) Depression 8 (9.9) Affect lability 6 (7.4) Abnormal
Slide 16: Conclusion
16 Conclusion Abbreviations: IDR = Individualised dosing regimen; MADRS = Montgomery-Åsberg Depression Rating Scale; OLE = Open-label extension; SAE = Serious adverse event; TEAE = Treatment-emergent adverse event; TRD = Treatment-resistant depression. The primary endpoint was met: GH001 administere
Slide 17: Poster Presentations
17 Poster Presentations Monday, October 13th, 12:35 – 14:00pm (Poster Area) Devlin F et al, Poster # PS03-2265 Tuesday, October 14th, 12:35 – 14:00pm (Poster Area) Baune BT et al, Poster # PS04-3243
Slide 18: Acknowledgments
18 Acknowledgments This trial was sponsored by GH Research Ireland Limited The sponsor would like to thank the participants in the trial The sponsor would also like to thank the investigators who conducted this trial Under the guidance of the authors, medical writing and editorial support was provid