UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of May, 2022.
Commission File Number: 001-40530
GH Research PLC
(Exact name of registrant as specified in its charter)
28 Baggot Street Lower
Dublin 2
D02 NX43
Ireland
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
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Form 20-F
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☒
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Form 40-F
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Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
On May 31, 2022, at the American Society of Clinical Psychopharmacology 2022 Annual Meeting, the principal investigator presented data related to a Phase 1/2 clinical trial of GH001 (GH001-TRD-102) conducted by GH Research PLC (the “Company”). A
copy of the presentation is attached hereto as Exhibit 99.1.
The fact that this presentation is being made available and furnished herewith should not be deemed an admission as to the materiality of any information contained in the materials. The information contained in the presentation is being provided
as of May 31, 2022 and the Company does not undertake any obligation to update the presentation in the future or to update forward-looking statements to reflect subsequent actual results.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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GH Research PLC
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Date: May 31, 2022
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By:
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/s/ Julie Ryan
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Name:
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Julie Ryan
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Title:
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Vice President, Finance
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EXHIBIT INDEX
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Exhibit No.
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Description
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Presentation for May 2022
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Exhibit 99.1
A Phase 1/2 Trial of GH001, a Vaporized 5-Methoxy-N,N-Dimethyltryptamine Formulation, inPatients with Treatment-Resistant Depression
(TRD) 1 Clinicaltrials.gov ID NCT04698603 GH001-TRD-102 ASCP 2022 Johannes Reckweg1, Cees van Leeuwen1, Cécile Henquet2, Therese van Amelsvoort2, Natasha Mason1, Riccardo Paci1, Theis Terwey3, Johannes G Ramaekers1 Faculty of Psychology
and Neuroscience, Maastricht University, Maastricht, Netherlands School Mental Health and Neuroscience, Maastricht University, Maastricht, Netherlands GH Research, Dublin, Ireland
... Remission Rates in TRD < 15% Established Therapies are Slow-Acting ~33% no remission despite 4 treatment steps Adapted
from Trivedi et al., Am J Psychiatry 2006 and Rush et al., Am J Psychiatry 2006 Average time to remission is ~6 weeks (STAR*D study, Remission Rate Over Time, Treatment Step 1 = Citalopram) (STAR*D study, Remission Rates Treatment Steps 1
to 4) 2 2 or more prior therapies = TRD GH001-TRD-102 ASCP 2022 The Problem for Patients with Depression
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 to induce peak experiences (PE), which may be a surrogate marker for therapeutic effects GH001
(5-MeO-DMT administration via a proprietary inhalation approach) Intraday individualized dosing regimen (IDR) for maximization of ultra-rapid remissions Single visit initial treatment, with no structured psychotherapy 5-MeO-DMT and
GH001 3 5-MeO-DMT GH001-TRD-102 ASCP 2022
Phase 1 Trial in Healthy Volunteers (GH001-HV-101, n=22) GH001 single doses of 2 mg, 6 mg, 12 mg, 18 mg and GH001 IDR (6, 12, 18 mg
intra-subject dose escalation) No SAEs, all ADRs mild (except two moderate), all ADRs resolved spontaneously, inhalation well-tolerated GH001 single dose with psychoactive effect dose response but high inter-subject variability GH001 IDR
controls inter-subject variability achieving a PE1 in all healthy volunteers 4 Clinicaltrials.gov ID NCT04640831; Reckweg et al, 2021 1The occurrence of a Peak Experience (PE) is assessed using the proprietary PE Scale, which averages
answers scored by the patient from 0 to 100 on a visual analog scale for three parameters of the experience: intensity, feelings of loss of control and profoundness. A PE is defined as an average score across these three parameters of at
least 75. PE ratings shown for IDR group represent values for the final administration of GH001. IDR, Individualized Dosing Regimen; SAE, Serious Adverse Event; ADR, Adverse Drug Reaction (an adverse event with a relationship code to the
investigational product of definite, probable, or possible, or where code is missing). GH001-TRD-102 ASCP 2022 PE Scale PE Threshold
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, Individualized Dosing Regimen 1Defined as inadequate response
to at least two adequate courses of pharmacological therapy or one adequate course of pharmacological therapy and at least one adequate course of evidence-based psychotherapy Phase 1 (Single Dose) Phase 2 (IDR) GH001 12 mg (n=4) GH001
18 mg (n=4) TRD1 (n=8) Primary Endpoint: Safety until day 7 TRD1 (n=8) Primary Endpoint: MADRS remission day 7 (MADRS≤10) GH001 IDR6, 12, 18 mg to achieve PE (up to 3 doses, 3h interval) GH001-TRD-102 ASCP 2022
Phase 1 (Single Dose) – Efficacy (MADRS) 6 2 of 4 patients in the 12 mg group and 1 of 4 patients in the 18 mg group had a MADRS
remission at day 7 2 of 4 patients in the 12 mg group had a PE and both had a MADRS remission at day 7, 0 of 4 patients in the 18 mg group had a PE GH001-TRD-102 ASCP 2022 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. MADRS Remission, Response, Improvement Rate at Day 7 MADRS from Screening to Day 7
Phase 2 (IDR) – Efficacy (MADRS) 7 GH001-TRD-102 ASCP 2022 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. Primary endpoint met: 7 of 8 patients (87.5%) had a MADRS remission at day 7, p<0.0001 7
of 8 patients had a PE and 6 of those had a MADRS remission at day 7 MADRS Remission, Response, Improvement Rate at Day 7 MADRS from Screening to Day 7
Phase 1 (Single Dose) and Phase 2 (IDR) – Safety 8 Adverse Drug Reaction, or ADR, an adverse event with a relationship code to the
investigational product of definite, probable, or possible, or where code is missingIDR, Individualized Dosing Regimen; C-SSRS, Columbia-Suicide Severity Rating Scale ADRs Phase 1 (Single Dose) Phase 2 (IDR) ADRs 12 mg (N=4) 18 mg
(N=4) IDR1 (N=8) MedDRA Preferred Term n n n Abdominal discomfort 1 Anxiety 2 Depressive symptom 1* Dizziness 1 Feeling abnormal 1 1 Flashback 1 1 2 Headache 2 1 3 Muscle discomfort 1 Muscle
spasms 1 Nausea 2* Paresthesia 1 Sensory disturbance 3 16-12 mg (N=6); 6-12-18 mg (N=2) GH001-TRD-102 ASCP 2022 Study Safety Group review No SAEs All ADRs mild, except three moderate* All ADRs resolved
spontaneously Inhalation well-tolerated No noteworthy changes in vital parameters, except for temporary, non-clinically relevant increase in heart rate and blood pressure shortly after administration of GH001 No clinically significant
changes in safety laboratory analyses, psychiatric safety assessments or measures of cognitive function No safety signal relating to suicidal ideation or suicidal behavior, based on C-SSRS and MADRS subscore item “suicidal thoughts”
Conclusions GH001 allows rapid and individualized dosing optimization A single dosing day with GH001 IDR achieved a rapid (within 24 hours) and sustained full remission
(7 days) of symptoms of depression in 7/8 patients (87.5%) with TRD GH001 was well tolerated, and no serious adverse events were reported Contacts GH Research: info@ghres.com / clinicaltrials@ghres.com Maastricht University:
j.ramaekers@maastrichtuniversity.nl Twitter: @PIMaastricht