GH Research announced that the FDA has placed a clinical hold on an IND that the company submitted for GH001 inhaled mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression, citing “Insufficient information to assess risks to human subjects.” The company said that it is waiting to learn more details from the FDA about the reasons for the clinical hold.
According to GH Research, the company submitted the IND for a Phase 1 trial that “is designed to support bridging to the clinical data generated with the externally-sourced inhalation device we currently use in our European Phase 2b trial such that we can initiate, subject to data and regulatory clearance, a subsequent global Phase 3 pivotal program using our proprietary device.”
The European Phase 2b trial of GH001 is expected to enroll about 80 patients with treatment-resistant depression and will evaluate GH001 versus placebo for the improvement of symptoms; topline data should be available by the end of 2024, the company said.
Read the GH Research press release.
