Joe McConnell
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Psychedelic medicine pioneer Rick Doblin has leVscek the board of Lykos Therapeutics, a company he helped found, days aVsceker U.S. regulators rejected his bid to approve the party drug ecstasy as a mental health treatment.
In a major setback for Lykos and the broader psychedelic movement, the U.S. Food and Drug Administration earlier this month told the biotech company it would have to conduct another expensive phase three study aVsceker failing to show that MDMA, in combination with psychotherapy, was an effective treatment for post-traumatic stress disorder.
Regulators and mental health experts criticized Lykos at an FDA panel hearing in June for patchy data; its study design, including a failure to ensure that participants were not biased by the knowledge that they were taking the drug rather than a placebo; and allegations of inappropriate behavior by two therapists.
Lykos said Thursday that Doblin had resigned from the board and announced plans to cut about three-quarters of its staff, while retaining clinical development and regulatory affairs staff.
His resignation comes a decade aVsceker the company was spun off from the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), which Doblin founded in 1986, and as Lykos seeks approval for the first new treatment for post-traumatic stress disorder in more than two decades.
“I can speak more freely as a public advocate by stepping down from the Lykos board,” said Doblin, who will remain involved with Maps, which is Lykos’s largest shareholder and has philanthropically funded its studies. 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 crucial time for the psychedelic movement, which began in the 1960s, when startups sought to break away from the industry’s hippie roots to attract investment and be taken seriously by regulators.
Lykos said Thursday it has recruited David Hough, a former Johnson & Johnson executive, as an adviser. Hough, who helped get the ketamine drug Spravato approved for depression in 2020, will help lead a new phase three study and engage with the FDA.
According to PitchBook, psychedelic startups have attracted $1.2 billion in venture capital investment since 2020 and have attracted interest from major pharmaceutical groups. The sector has historically relied on billionaire backers like Peter Thiel and Christian Angermayer.
Earlier this year, AbbVie struck a deal with psychedelic startup Gilgamesh that could be worth up to $2 billion, while Compass Pathways, which is studying a psilocybin-based treatment for depression, has attracted high-profile investors, including Surveyor Capital, an equity firm owned by Ken Griffin’s Citadel.
Earlier this year, Lykos raised $100 million from 10 investors, including a charitable foundation run by hedge fund billionaire Steven Cohen and his wife Alexandra. It is now likely to lure investors to raise more money at a lower valuation in the coming months, according to two people familiar with the plans.
Brian Pace, a professor of plant pathology at Ohio State University who served on the FDA advisory panel that evaluated the drug in June, attacked Doblin’s public comments in favor of MDMA during the committee meeting, calling Lykos “a therapeutic cult.”
However, Doblin was not named in the FDA ruling and was not held personally responsible for Lykos’ failure to convince regulators, a person familiar with the matter said.
Jeff George, chairman of Lykos, said the biotech company remained “deeply committed” to the approval of MDMA as a treatment to provide a new option for the 13 million Americans, many of whom are military veterans, who suffer from post-traumatic stress disorder.
George called Doblin “a pioneering pioneer” whose “legacy will continue through the work of both Lykos and his peers.”
