Irish biotech GH Research has said the phase 2 win for its inhaled depression drug has “paved the way for future commercial success.”
The inhaled mebufotenin candidate, dubbed GH001, was evaluated in the midstage study of 81 patients with treatment-resistant depression. The 40 patients who received GH001 saw an average 15.2 point reduction on the Montgomery-Åsberg Depression Rating Scale at Day 8, compared to an increase of 0.3 points among the 41 patients who received placebo.
As well as hitting this primary endpoint, GH001 also achieved the study’s secondary endpoints of showing clinically and statistically significant improvements on a clinical-rated tool, a scale of anxiety and quality of life questionnaire, when compared to placebo, the company said.
Professor of psychiatry Michael Thase, M.D., said “such a large and rapid effect, particularly one that may require only infrequent, short 1-3 hours clinic visits, has the potential to be a practice-changing treatment,” according to a statement in GH’s Feb. 3 release.
All treatment-emergent adverse events were mild or moderate with no severe adverse events observed, GH said, noting that there had been no evidence of treatment-emergent suicidal ideation or behavior after treatment with GH001.
Of the eight patients who discontinued early, one was related to an adverse event, the biotech added.
“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,” GH’s CEO Villy Valcheva, M.D., said in the release. “The ultra-rapid and profound reduction in depressive symptoms, coupled with sustained remission through infrequent, short treatment visits, positions us uniquely.”
GH is also evaluating GH001 in proof-of-concept studies for both bipolar disorder and postpartum depression. Meanwhile, the Dublin-based company is overseeing a phase 1 trial of healthy volunteers in the U.K. to evaluate GH’s proprietary aerosol delivery device for GH001.