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atai Life Sciences Announces Update on Beckley Psytech’s Phase 1/2a Trial of ELE-101 (IV Psilocin) for Major Depressive Disorder, with Initial Results from Phase 1 and First Patients Dosed in Phase 2a
atai Life Sciences has provided an update on Beckley Psytech's Phase 1/2a trial of ELE-101 for Major Depressive Disorder (MDD). ELE-101 is a synthetic psilocin formulation designed for a consistent and shorter treatment duration of approximately two hours. The Phase 2a study will assess the safety, tolerability, and efficacy of a single IV dose in 6-12 participants, with results expected in H2 2024.
Phase 1 results indicate ELE-101 was well-tolerated with no serious adverse events and exhibited a dose-proportional pharmacokinetic profile. Initial data suggests a reliable induction of short-duration psychedelic experiences. The trial aims to demonstrate that ELE-101 could offer rapid onset and reduced treatment variability compared to oral psilocybin, potentially reducing the resource burden on healthcare systems.
Full Phase 1 data will be published later, and ELE-101, along with other candidates like BPL-003 and VLS-01, is part of atai's pipeline targeting in-clinic treatments of around two hours.
Phase 1 results indicate ELE-101 was well-tolerated with no serious adverse events and exhibited a dose-proportional pharmacokinetic profile. Initial data suggests a reliable induction of short-duration psychedelic experiences. The trial aims to demonstrate that ELE-101 could offer rapid onset and reduced treatment variability compared to oral psilocybin, potentially reducing the resource burden on healthcare systems.
Full Phase 1 data will be published later, and ELE-101, along with other candidates like BPL-003 and VLS-01, is part of atai's pipeline targeting in-clinic treatments of around two hours.
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