GH Research Posts Data From Treatment-Resistant Depression Trial

GH Research PLC GHRS has reported the outcome of the Phase 2 part of a Phase 1/2 trial of GH001, an inhalable 5-MeO-DMT product candidate for treatment-resistant depression (TRD).
The trial met its primary endpoint with 7 of 8 patients (87.5%) in remission at day 7 after dosing.
According to FDA Guidance for Industry, a 7-day endpoint is an appropriate primary efficacy endpoint for rapid-acting antidepressants.
Of the 7 patients who had a remission at day 7, all were in remission beginning on day 1, with 5 in remission as early as 2 hours after dosing.
The patient who did not achieve remission at day 7 also improved on day 7 versus baseline.
6 of the 7 patients in remission had achieved peak experiences (PE) at their final dose. The mean change on the depression scale from baseline for all 8 patients at day 7 was -24.4 points (-76%).
No serious adverse events were reported. 7 of 8 patients experienced at least one adverse drug reaction, all of which were mild or moderate in intensity and all of which resolved spontaneously.
In addition, the company also reported preliminary safety results from a Phase 1 trial in healthy volunteers (GH001-HV-103).
GH Research ended Q3 with a cash balance of $280.7 million.
Price Action: GHRS shares traded higher by 13.1% at $21.78 on the last check Monday.

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