Ibogaine company receives $15 million from Google co-founder’s nonprofit; Could a road through federal land derail a planned psilocybin center in Oregon?; questions remain about FDA’s investigation
Plus: Beware the mushroom gummies, and the role of therapy in psychedelic-assisted therapy
Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.
Ibogaine company receives $15 million from Google co-founder’s nonprofit
This week, the Financial Times reported that a nonprofit called Catalyst4, funded by Google co-founder Sergey Brin, has invested $15 million in a psychedelics biotech start-up called Soneira. Soneira is developing the psychedelic ibogaine to treat traumatic brain injury, building on research led by Stanford University researcher Nolan Williams.
The company’s website contains no information, but it appears Soneira filed for incorporation in August 2023. A month later, Soneira and Stanford University filed two patent applications for oral forms of iboga alkaloids and methods of treatment using an iboga alkaloid.
For new patents to be granted, applicants must show that their work is novel and non-obvious. Two weeks ago, non-profit Porta Sophia announced that they submitted documents to the U.S. Patent and Trademark Office that they believe disprove Soneira’s novelty claims. Porta Sophia’s submissions, including its most recent submission on Soneira’s patent applications, are intended to give patent examiners and the general public more context for what is and is not truly novel in psychedelics.
Could a road through federal land derail a planned psilocybin facility in Oregon?
In Deschutes County, Oregon, a psilocybin facility’s application is up in the air as commissioners decide whether its operations could potentially violate federal laws. The facility’s operators filed an application in 2023 to open a psilocybin center outside the city of Bend, but their application was denied in April 2024 after a March 2024 hearing. At this hearing, county officials raised concerns that because roads leading to the property were federally owned by the Bureau of Land Management, transportation of federally illegal psilocybin mushrooms may not be legal. Last week, commissioners held another public hearing in which the applicant appealed the county’s decisions. At the meeting, many spoke out against granting the application.
Psilocybin has long been a controversial issue in Deschutes County. In 2022, when many Oregon counties and cities were considering opting out of Measure 109, the initiative that established the state’s psilocybin services, the county held multiple contentious public hearings about whether to allow psilocybin in the county, but voters ultimately decided to allow it.
The county is allowing public comment on the facility’s plans through the end of the month and will make a decision on the application in August.
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Questions remain about FDA’s investigation of Lykos clinical trials
During the U.S. Food and Drug Administration’s June 4 advisory committee meeting to discuss Lykos Therapeutics’s application for MDMA in the treatment of PTSD, FDA’s Division of Psychiatry director Tiffany Farchione said that the agency would be investigating claims of misconduct and data suppression. But recent reporting from STAT questions whether the FDA has reached out to trial participants, especially those who have raised concerns about the study.
According to the STAT reporting, published last Friday, the FDA has not yet reached out to David Rind, chief medical officer of the Institute for Clinical and Economic Review, a nonprofit research group that published a report detailing alleged misconduct and data suppression. “Given some of the things we commented on, I wondered whether [the FDA] might want additional information,” Rind told STAT. “I’m a little surprised they haven’t checked.”
The agency is set to make a ruling in the next three weeks about Lykos’s application.
Beware the mushroom gummies
A dispatch from University of Virginia physicians published in the U.S. Centers for Disease Control’s Morbidity and Mortality Weekly Report says that in the last year, five people had been hospitalized after ingesting “nootropics” gummies. Four of those hospitalized were adults; one was a 3-year old child. Adult patients all reported confusion, anxiety, nausea, and rapid heartbeat; one reported chest pain, and the child experienced vomiting. All were discharged within a day.
These gummies were marketed as containing “proprietary mushroom nootropic blends,” or Amanita muscaria, which is a species of mushroom that is legal in the U.S. But testing revealed that all of the gummies actually contained psilocybin and psilocin. “The presence of the DEA schedule I substances psilocybin and psilocin in products legally sold at retail shops in Virginia represents a potential risk to the public,” the authors write.
The role of therapy in psychedelic-assisted therapy
As some companies are trying to develop psychedelic treatments that don’t involve therapy, two researchers argue in the Psychiatric Times that therapy might be what matters most in psychedelic treatments. “This conclusion and its implications are not new to therapists or psychotherapy researchers,” write Ohio State University psychiatrist Adam W. Levin and psychedelics researcher Alan K. Davis. “Decades of psychotherapy research has demonstrated time and time again that a stronger alliance is associated with positive treatment outcomes.” Indeed, in some psychedelic clinical trials, therapeutic alliance — the trust and bond between a patient and facilitator — predicts positive outcomes, and participants have reported that the human connection was what made the treatment work.
Levin and Davis say that minimizing the role of therapy is right out of pharmaceutical companies’ playbook. “Insurers have used exaggerated or misinterpreted findings for the efficacy of brief therapeutic interventions to justify paying for therapy only to the point of acute stabilization, typically 8 weeks, despite evidence that as many as 50% of patients require 21 sessions before sustained clinical improvement,” they write. They call for researchers — and the FDA — not to discount the role of therapy in psychedelic studies’ outcomes.
Voters in Lake Oswego, Oregon will be voting in November on whether to allow psilocybin services. In 2022, Lake Oswego was among the many counties and cities that opted out from Measure 109.
A group of scientists has published a consensus statement to outline their support for Lykos’s new drug application for MDMA in the treatment of PTSD. The letter has 27 signatories, 12 of whom have received funding or support from Lykos or served as a researcher, consultant or clinician in its clinical trials.
Could shrooms have shaped human consciousness? Popular Mechanics explores why it’s difficult to find evidence for this intriguing theory.
For DoubleBlind, UC Berkeley-Ferriss fellow Webb Wright explores the underground mushroom market, which according to Wright is “rife with counterfeits and adulterants.”
Mike Tyson is selling a magic mushroom growing kit called “Mikeadelics,” according to Maxim.
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