Irish biopharm company GH Research said that it has completed inhalation toxicology studies of GH001 inhaled mebufotenin (5-MeO-DMT) necessary to address the FDA’s 2023 clinical hold on an IND that the company had submitted for a Phase 1 study of GH001 for the treatment of treatment-resistant depression. In addition, the company announced that 2 Phase 2a proof of concept trials of GH001 met their primary endpoints.
According to the GH Research, inhalation toxicology studies requested by the FDA related to the clinical hold have been completed, with the results supporting GH Research’s assertion that histology findings in rats are specific to rats. The company said that it is in the process of preparing additional design verification information related to its proprietary delivery device at the agency’s request and that it is expecting to submit its complete response to the IND hold by mid-2025.
A European Phase 2b trial of GH001 in patients with treatment-resistant depression is underway and has completed enrollment, the company said, with top-line data expected in the first quarter of this year.
Read the GH Research press release
