With plans in place to launch global pivotal testing of GH-001, its inhaled version of psychedelic mebufotenin (5-MeO-DMT), in treatment-resistant depression in 2026, GH Research plc reported the lifting of a U.S. FDA clinical hold, enabling U.S. subject enrollment. The firm now will seek a meeting with the agency to discuss trial design.
The potential of psychedelic substances such as lysergic acid diethylamide (LSD) and psilocybin in treating various neuropsychiatric disorders has received increased attention in recent times. These compounds are believed to exert their effects through the serotonin 5-HT2A receptor.
Beckley Psytech Ltd. is advancing lead BPL-003 psychedelic therapy on two fronts, opening phase IIa trials in alcohol use disorder and in treatment-resistant depression.
Over the past few years, the pandemic clearly has put a spotlight on vaccines and the infectious disease space. But the struggle to adjust in COVID-19’s wake also brought into stark relief another high unmet need. “Coming out of COVID, there was a mental health focus coming into play,” said Andrew Levin, partner and managing director at investment firm RA Capital Management who is also serving as interim CEO at Lusaris Therapeutics Inc., a 2021 startup targeting neuropsychiatric and neurological conditions, with an initial focus on treatment-resistant depression.
