Psychedelic Drug Developers Atai, Cybin, and GH Research Discuss Trial Design and FDA Expectations
核心洞察
Executives from Atai Life Sciences (搜索), Cybin (搜索), and GH Research addressed psychedelic trial design challenges at a recent investor event, focusing on Lykos Therapeutics (搜索)' FDA rejection.
Atai's CEO, Srini Rao, emphasized that the FDA's standards for psychedelics are consistent with other drug classes, citing Janssen's Spravato as a successful precedent.
Cybin (搜索)'s CSO, Amir Inamdar, critiqued Lykos' psychotherapeutic approach, raising concerns about ethical considerations and the feasibility of psychotherapy during active dosing sessions.
Executives from Atai Life Sciences (搜索), Cybin (搜索), and GH Research convened at TD Cowen’s September 26th panel, Advancement in Psychedelic Therapies for Neuropsychiatry, to discuss the evolving landscape of psychedelic drug development, addressing challenges in trial design and regulatory expectations in light of Lykos Therapeutics (搜索)' recent FDA rejection of their new drug application (NDA).
Consistent FDA Standards
Atai CEO Srini Rao addressed concerns about differing regulatory standards for psychedelic drugs, stating that the FDA has made it clear that "the bar is not different when it comes to psychedelics." He pointed to Janssen's esketamine nasal spray, Spravato, approved in 2019, as a relevant precedent, noting its successful navigation of the FDA approval process.
Critique of Psychotherapeutic Approaches
Cybin (搜索) CSO Amir Inamdar offered a critical perspective on Lykos' therapeutic model, suggesting that their psychotherapeutic approach "was not evidence-based and put patients at risk of ethical violations." Inamdar elaborated that therapists involved in the study may have operated under the assumption that patients needed to "suffer for healing."
Cybin's Alternative Approach
Inamdar further clarified Cybin (搜索)'s distinct approach, stating that they are "not really doing psychedelic-assisted psychotherapy," which he believes is unique to MDMA. He argued that "it is virtually impossible to do any psychotherapy during the active dosing therapy sessions because patients are uninstructable," likening the experience to "dropping an atom bomb on the brain."