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Psychedelic medicine pioneer Rick Doblin has left the board of Lykos Therapeutics, a company he helped found, days after US regulators rejected its bid to approve party drug ecstasy as a mental health treatment.
In a major setback for Lykos, and the wider psychedelics movement, the US Food and Drug Administration told the biotech earlier this month it would need to run another costly phase-three trial after failing to prove that MDMA, combined with psychotherapy, was an effective treatment for post-traumatic stress disorder.
Regulators and mental health experts criticised Lykos at an FDA committee hearing in June over patchy data; the design of its trials, including failing to ensure participants were not biased by knowing they had taken the drug instead of the placebo; and allegations of inappropriate behaviour by two therapists.
Lykos said on Thursday that Doblin had left its board as it announced plans to cut around three-quarters of its workforce while retaining staff working on clinical development and regulatory affairs.
His exit comes a decade after the company was spun out of the non-profit Multidisciplinary Association for Psychedelic Studies (Maps), which Doblin founded in 1986, and comes as Lykos tries to secure approval for the first new PTSD treatment in more than two decades.
“I can speak more freely as a public advocate by resigning from the Lykos board,” said Doblin, who will remain involved with Maps, which is Lykos’s biggest shareholder and philanthropically funded its trials. He added that he was “deeply saddened” by the FDA’s decision but “heartened” by Lykos’s continued push to get MDMA approved.
Doblin’s departure comes at a pivotal moment for the psychedelics movement, which first flourished in the 1960s, as start-ups attempt to move away from the sector’s hippie roots in order to attract investment and be taken seriously by regulators.
Lykos said on Thursday that it was drafting in David Hough, a former Johnson & Johnson executive, as an adviser. Hough, who helped to get the drugmaker’s ketamine-based medicine Spravato approved in 2020 to treat depression, will help with running a fresh phase-three trial and on engagement with the FDA.
Psychedelic start-ups have attracted $1.2bn in venture capital investment since 2020, according to PitchBook, and have drawn interest from major pharmaceutical groups. Historically the sector has relied on billionaire backers such as Peter Thiel and Christian Angermayer for funding.
AbbVie earlier this year struck a deal with psychedelic start-up Gilgamesh that could be worth up to $2bn, while Compass Pathways, which is studying a psilocybin treatment for depression, has attracted blue-chip investors, including Surveyor Capital, an equities business owned by Ken Griffin’s Citadel.
Earlier this year, Lykos raised $100mn from 10 investors, including a charitable foundation run by hedge fund billionaire Steven Cohen and his wife Alexandra. It is now likely to tap investors for more money at a lower valuation in the coming months, according to two people familiar with the plans.
Brian Pace, a lecturer in plant pathology at Ohio State University who participated in the FDA advisory panel assessing the drug in June, took aim during the committee meeting at Doblin’s public comments advocating for MDMA, calling Lykos “a therapy cult”.
However Doblin was not named in the FDA’s ruling, and has not been personally blamed for Lykos’s failure to convince regulators, a person familiar with the matter said.
Jeff George, Lykos’s chair, said the biotech remained “deeply dedicated” to getting MDMA approved as a treatment to provide a new option for the 13mn Americans, many of whom are military veterans, suffering from PTSD.
George called Doblin “a trailblazing pioneer” whose “legacy will continue through the work of both Lykos and its peers”.
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