GHRS - GH Research's Psychedelic Drug Candidate For Depression Meets FDA: Clinical Program On Hold | Benzinga
After the usual 30-day review period, the Food and Drug Administration (FDA) placed GH Research’s (NASDAQ: GHRS) Investigational New Drug (IND) application for a Phase 1 clinical trial of proprietary inhalable 5-MeO-DMT compound GH001 on clinical hold due to "insufficient information to assess risks on human subjects,” indicating it will issue a letter with additional details within 30 days time.
The IND application is meant to enable a Phase 1 healthy volunteer clinical study on GH001 administered via the company’s proprietary aerosol delivery device.
The clinical-stage biopharma company is still advancing GH001’s clinical development for Treatment-Resistant Depression (TRD) outside the U.S.
Following the successful completion of a Phase 1/2 trial in patients with TRD, recruitment for a European multi-center Phase 2b trial in TRD patients is underway, where GH001 will be dosed through an externally sourced inhalation device.
Combined data from both trials would support a subsequent global Phase 3 pivotal program (subject to approval) using this proprietary device.
The company ...