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Immediate Impact

February 3, 2025

GH Research Announces Phase 2b Trial Results with GH001 in Treatment Resistant Depression

Background


GH Research PLC is a clinical-stage biopharmaceutical company developing novel and proprietary mebufotenin therapies for the treatment of patients with treatment-resistant depression (TRD).
Its lead product candidate, GH001, is formulated for 5-MeO-DMT administration via a proprietary inhalation approach.

The Details

  • This represents a significant advancement in the field of psychedelic research with implications for further development of molecules with fast, therapeutic action and sustained durability with re-treatment.
  • This study found greater than 50% remission rates without the need for concomitant psychotherapy which has been traditionally used in many psychedelic research studies and has significant implications both for GH Research and for future investments in rapid-acting antidepressants and other molecules with psychedelic properties.

The Source

The phase 2b double blind TRD study results GH001 (5-MeO-DMT) were impressive but in need of replication. MADRS improvement of -15.5 on Day 8 (p<0.0001). Remission rate of 57.5% for 40 patients on active medication at Day 8 as compared with 0% in the 40 placebo patients (p<0.0001). 77.8% of the OLE completers were in remission at the 6-month visit, with infrequent treatments. Patients who had remission on Day 8 after their first active treatment had a 91.7% remission rate at 6 months
This represents a significant advancement in the field of psychedelic research with implications for further development of molecules with fast, therapeutic action and sustained durability with re-treatment.
This study found greater than 50% remission rates without the need for concomitant psychotherapy which has been traditionally used in many psychedelic research studies and has significant implications both for GH Research and for future investments in rapid acting antidepressants and other molecules with psychedelic properties.

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 Discussion Replay 


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