Psychedelics
Mike Davis previously worked as clinical team leader at the FDA’s Division of Psychiatry before serving as chief medical officer for Usona Institute, a research organization advancing psychedelic science.
Although the company withheld detailed findings from the study of treatment-resistant depression, analysts at Stifel called COMP360’s efficacy “more than good enough” for registrational purposes.
In an interview on Friday, FDA Commissioner Marty Makary threw his weight behind psychedelic therapies, noting that patients taking these substances experience significant benefits for various neuropsychiatric conditions.
After the rejection of Lykos Therapeutics’ MDMA-based PTSD treatment tempered excitement for psychedelic therapeutics, a recent approval and positive data are generating new momentum, which experts expect to continue throughout 2025 and 2026.
In a Phase IIb trial, GH001 elicited significant drops in treatment-resistant depression. The news comes less than two weeks after J&J secured FDA monotherapy approval for its esketamine nasal spray Spravato in the same indication.
The results, which come on the heels of the FDA’s approval of J&J’s esketamine nasal spray Spravato as a monotherapy for treatment-resistant depression, could serve to further bolster a space hit hard by the rejection of Lykos’ MDMA-based PTSD therapy in August 2024.
Lykos Therapeutics is currently working out ways to fund an additional Phase III study for its MDMA-assisted PTSD therapy following an FDA setback last year.
Phase II results for Cybin’s psilocin therapy showed remission rates of 71%, but just eight patients made it to the 12-month milestone.
In another delay for the psychedelic treatment space, Compass Pathways announced adjusted timelines for two Phase III trials of its psilocybin to address treatment-resistant depression.
In a short statement Friday, Lykos Therapeutics expressed optimism about a recent meeting with the regulator to discuss next steps for the embattled program, following the FDA’s rejection in August 2024.
PRESS RELEASES