Pα+ Psychedelic Bulletin #176: Drug Developers Discuss Trial Design; Massachusetts Vote is Too Close to Call as Last-Minute Donations Flow In; SEC Charges ‘Pump and Dump’ Scheme

Speaking at TD Cowen’s September 26th panel, Advancement in Psychedelic Therapies for Neuropsychiatry, execs from atai Life Sciences, Cybin, and GH Research fielded questions on Lykos’ new drug application (NDA), psychedelic trial design, and the broader field of psychedelic candidates.
A substantial portion of the panel discussion was dedicated to discussing Lykos Therapeutics’ recent FDA rejection, with speakers unsurprisingly keen to continue distancing themselves from the MDMA drug developer’s fate. (See, for example, ‘They Not Like Us’ — Psychedelic Drug Developers Emphasise Avoidance of Lykos’ Perceived Pitfalls.)
atai CEO Srini Rao told the audience that the FDA has made it clear, in its decision, that “the bar is not different when it comes to psychedelics”, adding that, for this class of drugs, ‘the true precedent is actually Spravato’, Janssen’s esketamine nasal spray product first approved in 2019. Rao pointed out that Janssen ‘got it through on the first go-around’, having gained the endorsement of an Advisory Committee and then the agency itself.
Amir Inamdar, Cybin’s CSO, agreed with Rao’s assessment: ‘FDA will apply the same standard’, he said, apparently rejecting the notion that the agency has more rigorous expectations for psychedelic programs than others.
Inamdar then went on to offer up what he saw as significant issues with Lykos’ program. The company’s psychotherapeutic approach ‘was not evidence-based and put patients at risk of ethical violations’, he told listeners. Study therapists, according to Inamdar, were under the impression that they could assess patients’ needs, ‘including that they need to suffer for healing’.
Turning to Cybin’s protocol, the CSO said that the company is ‘not really doing psychedelic-assisted psychotherapy’, which he said ‘is unique to MDMA’. “It is virtually impossible to do any psychotherapy during the active dosing therapy sessions”, Inamdar continued, “because patients are uninstructable.” “It’s like dropping an atom bomb on the brain”, he said of the active dosing session, arguing that this makes psychotherapeutic processes unworkable.

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