GH Research announced that a Phase 2b clinical trial of GH001 inhaled synthetic mebufotenin (5-MeO-DMT) in patients with treatment-resistant depression met its primary endpoint, demonstrating a significant reduction in depression symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) on Day 8 post dose. All secondary endpoints were also met, the company said.
GH Research recently announced that a Phase 2a trial of GH001 had met its primary endpoint and that the company had completed studies to address the FDA’s clinical hold on an IND for a Phase 1 trial of the inhaled psychedelic. The agency placed the clinical hold on that IND in 2023.
The Phase 2b study, which was conducted in Europe, enrolled 81 patients with treatment-resistant depression who received either GH001 or placebo on a single day. According to GH Research, patients who received GH001 did not report any sedative or dissociative effects; patients were able to leave the facility within an hour post-dose; and no serious adverse events were observed. At 8 days post dose, the company said, the GH001 group reported a 15.2 point reduction from baseline in total MADRS score compared to 0.3 point reduction in the placebo group.
Of the 81 patients, 54 have completed a 6-month open label extension, with ~78% in remission at 6 months, and 9 are still participating. The company said that 18 patients dropped out of the open label extension, one of which stopped participating due to an adverse event.
GH Research CEO Villy Valcheva commented, “Today, as we share our unprecedented positive Phase 2b data, we celebrate a significant milestone in our journey to interventional psychiatry and pave the way for our future commercial success with GH001 in treatment-resistant depression. The ultra-rapid and profound reduction in depressive symptoms, coupled with sustained remission through infrequent, short treatment visits, positions us uniquely.”
Read the GH Research press release
