GH Research Reports Positive Phase 2b Results for Inhaled 5-MeO-DMT in Treatment-Resistant Depression
GH Research announced positive topline results from its Phase 2b study of GH001, an inhaled formulation of 5-MeO-DMT, for treatment-resistant depression (TRD)2.
The study met its primary endpoint, showing a placebo-adjusted MADRS reduction from baseline of -15.5 at day 82.
57.5% of patients in the GH001 arm achieved remission at day 8, compared to 0% in the placebo group2.
All secondary endpoints were met, and the drug was well-tolerated with no serious adverse events reported2.
The positive results led to a significant increase in GH Research's market capitalization, with shares doubling over the past few days2.
GH001 is designed to provide a rapid-acting treatment option, with potential for remission after a single dosing day5.
Previous Phase 1/2 data showed remission rates of 25-50% with a single dose and 87.5% with an individualized dosing regimen5.
The company is also developing GH001 for other indications, including bipolar II disorder and postpartum depression5.
Despite the positive results, questions remain regarding the FDA's clinical hold on U.S. development and the intellectual property landscape surrounding the drug2.
Sources:
2. https://psychedelicalpha.com/news/gh-research-reports-strong-phase-2b-results-for-5-meo-dmt-in-treatment-resistant-depression