A psychedelic therapy being developed by atai Life Sciences and Beckley Psytech has met its primary endpoint in a Phase IIb study in patients with treatment-resistant depression.
The nasal spray, BPL-003 (intranasal mebufotenin benzoate), significantly reduced depression symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS).
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In the 12mg cohort, there was a mean decrease of 11.1 points from baseline compared to a 5.8-point reduction in the 0.3mg comparator group. The 8mg cohort reported a MADRS score reduction of 12.1 points in the Phase IIb study (NCT05870540).
Statistical significance in MADRS scores was achieved within two days of dosing in both treatment arms, with a durable benefit of at least two months.
Based on the data, the companies are planning to advance the 8mg dosing to Phase III studies, with plans to engage with regulatory authorities, including the US Food and Drug Administration (FDA), for pivotal trial designs of the psychedelic in treatment-resistant depression in the coming months.
Investors seem happy with the update, with Germany-based atai Life Sciences stock, listed on the Nasdaq exchange, opening 20% higher on 1 July ($2.63) than the 30 June close ($2.19). UK-based Beckley Psytech is a private company.
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By GlobalDataWhile the drug was well-tolerated at all doses, there were some dose-related tolerability variations with administration site discomfort, nausea, headache, blood pressure and anxiety. This suggests the 8mg dose was better tolerated than the 12mg dose, further supporting the advancement of this dose.
The company is now running an open-label study (NCT05660642) to evaluate the longer follow-up of the therapy. The open-label study will evaluate the efficacy and safety of a second, 12mg dose of BPL-003, with data expected in Q3 2025.
Kadima Neuropsychiatry Institute director Dr David Feifel said: “What stands out in these results is that a single administration of BPL-003 in patients with treatment-resistant depression was generally well tolerated and produced a robust antidepressant effect that emerged rapidly and was solidly sustained for at least two months.”
One notable benefit of BPL-003 is that patients dosed are ready for discharge within two hours of dosing, something which has been an issue with studies of other psychedelics. With other psychedelics, patients need to be monitored for up to eight hours post-dosing, which puts strain on site staff, experts have told Clinical Trials Arena.
The psychedelic sector has been difficult for companies to break into, with no approved therapies yet on the market. In 2024, Lykos Therapeutics’ MDMA-based therapy was rejected by the FDA, with the agency requesting further studies. Last month, Compass Pathway announced data for its psilocybin candidate, which, despite meeting the primary endpoint, the company’s stock crashed nearly 50% on the data.
