Atai Life Sciences and Beckley Psytech announced positive topline results from their Phase 2b study of BPL-003, an intranasal formulation of 5-MeO-DMT, for treatment-resistant depression. The study demonstrated statistically significant reductions in depressive symptoms with single doses of 8mg and 12mg compared to control, with effects observable within one day and sustained up to eight weeks. The promising data have positioned the therapy for late-stage development, with some analysts suggesting BPL-003 could become a blockbuster treatment. Concurrently, Atai Life Sciences and its partner Recognify Life Sciences reported that their experimental drug inidascamine, aimed at cognitive impairment associated with schizophrenia (CIAS), did not meet the primary endpoint in a Phase 2b trial. Despite this, the drug showed modest, consistent numerical improvements across cognitive and functional measures and maintained a favorable safety profile. Atai owns just over 50% of Recognify and has invested approximately $30 million over five years in the program. Following the trial failure, Atai has indicated it will step back from the schizophrenia drug development.
$ATAI - Atai-Partnered Schizophrenia Drug Flunks Mid-Stage Trial - https://t.co/hzI8VwWuS5
$ATAI - Atai backs away from schizophrenia drug after trial failure - https://t.co/icILGHMs10 via @BioPharmaDive
Atai backs away from schizophrenia drug after trial failure https://t.co/JYRwflOopw by @realJacobBell $ATAI - 11%