The Phase 2 part of the clinical trial for GH001, conducted by GH Research PLC, demonstrated significant efficacy in treating treatment-resistant depression (TRD). The trial achieved its primary endpoint with 7 out of 8 patients (87.5%) reaching remission, defined by a Montgomery–Åsberg Depression Rating Scale (MADRS) score of ≤10, at day 7 after dosing (p<0.0001). The mean change from baseline in MADRS at day 7 was -24.4 points, representing a 76% reduction (p<0.0001).
Patients in the trial followed a proprietary GH001 individualized dosing regimen, receiving up to three increasing doses of GH001 (6 mg, 12 mg, and 18 mg) on a single day. The regimen was designed to achieve a peak experience (PE), with 7 patients achieving a PE at their final dose. The trial also reported that GH001 was well tolerated, with no serious adverse events (SAE) reported. Adverse drug reactions (ADRs) were mild or moderate and resolved spontaneously.
In addition to the Phase 2 trial results, GH Research PLC announced positive preliminary safety results from a Phase 1 clinical pharmacology trial in healthy volunteers. This trial involved 46 healthy volunteers and investigated the safety of GH001 at different doses, including a proprietary individualized dosing regimen. No SAEs were reported, and all ADRs were mild and resolved spontaneously. The preliminary results support the safety profile of GH001 for both single doses and the individualized dosing regimen.
GH Research PLC is focused on developing novel 5-MeO-DMT therapies for psychiatric and neurological disorders, with GH001 being its lead product candidate. The company believes that GH001 has the potential to revolutionize the treatment of TRD, based on the observed clinical activity and safety profile in the trials conducted so far.
