atai Life Sciences (NASDAQ:ATAI, ETR:9VC) has hailed positive results from its investee Beckley Psytech’s Phase 2a study of its novel DMT formulation BPL-003 in patients with treatment-resistant depression.
The biopharmaceutical company said during the open-label study, a single 10mg dose of BPL-003 – a novel, synthetic, patent-protected benzoate salt formulation of 5-MeO-DMT (mebufotenin) – was administered intranasally along with psychological support and induced a rapid antidepressant response in 55% of patients the day after dosing.
The 12-patient study enrolled individuals with moderate-to-severe treatment-resistant depression who were not taking concomitant antidepressants.
According to the results, 55% of the patients were in remission at week 4 and 45% at week 12, which atai highlighted represented the longest known follow-up of depression outcomes in a clinical study of 5-MeO-DMT.
The efficacy of the drug was evaluated using the Montgomery–Åsberg Depression Rating Scale (MADRS).
The drug demonstrated a good safety profile and was well-tolerated, with no serious adverse events reported.
atai noted that the acute effects were resolved in less than two hours on average, which suggests that BPL-003 could offer a shorter in-clinic treatment time than other psychedelic treatments being developed.
“With around half of treatment-resistant depression patients in remission three months after just a single dose of BPL-003 in this study, we are particularly excited about its antidepressant durability potential,” atai CEO Florian Brand said in a statement.
“The results indicate that BPL-003 could offer a scalable, single-dose administration within the two-hour in-clinic treatment paradigm successfully established by Spravato.”
An extension to this Phase 2a open study is enrolling patients with treatment-resistant depression who are on stable doses of antidepressants to evaluate the safety and efficacy of co-administering BPL-003.
Meanwhile, a Phase 2b study is underway investigating the effects of a single 12mg or 8mg dose of BPL-003 against a sub-perceptual dose of 0.3mg in 225 patients with treatment-resistant depression. Topline results are expected in the second half of 2024.
“The positive data from the Phase 2a study is highly encouraging as we await the results of the larger Phase 2b study anticipated later this year,” Brand said.
atai acquired a 35.5% stake in Beckley Psytech, a private clinical stage-biopharmaceutical company, in January 2024.