Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed
California Governor Vetoes Psychedelics Decriminalization Bill
California governor Gavin Newsom has vetoed a major psychedelic decriminalization bill. The legislation has been making its way through California’s congress for years, finally passing the Assembly and Senate last month.
But all hope is not lost, as the governor expressed support for a more comprehensive bill that establishes guidelines for regulated therapeutic access to psychedelics.
New Study Shows Spravato Effective When Combined With SSRIs
A new study published in the New England Journal of Medicine found that Spravato’s esketamine was more effective than a commonly prescribed drug in treating treatment-resistant depression.
This study looked at 336 adults with treatment-resistant depression who were given Spravato in addition to the antidepressant medication they were already taking (SSRI or SNRI). A separate group of 340 patients used quetiapine with their treatments.
Results: After 8 weeks, the esketamine group showed higher remission rates than the quetiapine group: 27.1% vs. 17.6%. The Spravato group also had better rates of no relapse through 32 weeks: 21.7% vs. 14.1%.
California Passes Bill Allowing Doctors to Prescribe Psychedelics If Federally Re-Scheduled
California Governor Gavin Newsom has signed bill AB 1021, a piece of legislation that allows California health professionals to legally prescribe and dispense any Schedule I drug that is re-scheduled under the Controlled Substances Act (CSA).
The bill does not specify psychedelics, so it will allow any Schedule 1 substance — from heroin to peyote — to be prescribed by California doctors if rescheduled federally.
atai Life Sciences Completes Phase 1 Study of Oral DMT
Atai Life Sciences has completed its Phase 1 study of VLS-01 oral DMT. VLS-01 is a synthetic form of N,N-dimethyltryptamine (DMT) under development for treatment-resistant depression (TRD). Results from the Phase 1 show:
- VLS-01 DMT was well-tolerated with a favorable safety profile
- Data confirmed delivery of DMT via the oral route at levels comparable to those achieved with IV administration
- Company plans to further optimize VLS-01 in preparation for a Phase 2 study in treatment-resistant depression (TRD)
GH Research: Updates on Clinical Development Programs
5-MEO-DMT developer GH Research has provided an update on its main clinical programs. The company is notoriously short on communications outside of the obligatory company updates, so investors are always keen on getting a glimpse of GH Research’s latest announcements. Main points include:
- Currently recruiting for a European Phase 2b trial of GH001 in patients with treatment-resistant depression (TRD). Top-line data available in the third or the fourth quarter of 2024.
- Submitted an Investigational New Drug Application (IND) for GH001 with the FDA to initiate a Phase 1 trial with GH001 administered using proprietary aerosol delivery device (GH001-HV-106).
- The FDA has placed the requested IND on clinical hold due to “Insufficient information to assess risks to human subjects”. GH Research is awaiting more details and plans to provide an update at the next earnings release in November 2023.
