Atai Life Sciences, a clinical-stage biopharmaceutical firm engaged in mental health disorders, recently declared the positive preliminary results from Beckley Psytech's Phase 2a open-label study of BPL-003 for Treatment Resistant Depression (TRD). The news led to around a 4.1% rise in Atai shares on the Nasdaq, putting each share at $1.80 in pre-market activity.
The study's latest data implies that, relative to other psychedelic treatments currently under research, BPL-003 might provide a shorter time for in-clinic treatment. It was also announced that a Part 2 extension of this Phase 2a open-label study is now accepting TRD patients who are on stable oral antidepressant doses, to determine the safety and effectiveness of BPL-003 co-administration.
Beckley Psytech, a private clinical-stage biopharmaceutical company in which Atai owns a 35.5% stake, is responsible for developing BPL-003, a short-duration psychedelic tryptamine known as 5-MeO-DMT that binds to numerous serotonergic receptors. BPL-003 is an innovative, synthetic, patent-secured benzoate salt formulation of 5-MeO-DMT, administered through the nose.
The open-label Phase 2a study looked at the safety, tolerability, and effectiveness of a single 10mg dose of BPL-003, together with psychological support, in patients with moderate-to-severe TRD who weren't taking concomitant antidepressants. Initial trial results showed that this single 10mg dose of BPL-003 was well-tolerated and led to a quick onset of antidepressant effect, enduring in patients who are living with TRD. Side effects were primarily mild or moderate, with nasal discomfort, headaches, nausea, and vomiting being the most common ones. No serious side effects were reported.
Atai Life Science's CEO and Co-Founder, Florian Brand, emphasised the Phase 2a study's positive data. He said that around half of TRD patients went into remission after only a single dose of BPL-003. He also noted the promising potential of BPL-003 for durable antidepressant effects and its suitability for a scaled, single-dose administration within the two-hour in-clinic treatment paradigm established by Spravato.
A randomized, quadruple-masked, controlled Phase 2b study of BPL-003 is presently being conducted and investigates the effects of single doses of 12mg or 8mg of BPL-003 versus a sub-perceptual dose of 0.3mg on 225 TRD patients.
