GH Research Posts Data From Treatment-Resistant Depression Trial
- GH Research PLC (NASDAQ: 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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