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Partners Beckley Psytech and atai Life Sciences (NASDAQ:ATAI) have jointly announced positive initial results from a Phase 2a study of Beckley's novel formulation of 5-MeO-DMT in Treatment Resistant Depression (TRD.)
See: Atai Invests $50M In Beckley Psytech For Short-Duration Psychedelics Development
BPL-003 is a synthetic and patent-protected benzoate salt formulation of 5-MeO-DMT (aka mebufotenin) designed for intranasal administration. The open-label study assessed safety, tolerability and efficacy of the compound at a single 10mg dose, alongside psychological support, in patients with moderate-to-severe TRD (who withdrew from concomitant antidepressants.)
The study's initial findings reflect treatment of 11 participants, who were followed for 12 weeks post-dosing. Efficacy was assessed using the widely known and accepted Montgomery–Åsberg Depression Rating Scale (MADRS.)
The single 10mg dose resulted in a rapid onset and durable antidepressant effect in patients with TRD, which affects approximately 100 million people worldwide. Importantly, these findings are believed to represent the longest known follow-up of depression outcomes in a clinical study of 5-MeO-DMT.
Specifically:
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Beckley Psytech's CEO Cosmo Feilding Mellen said the team is thrilled with the evidence that a single dose of BPL-003 delivered a rapid and durable antidepressant response in patients with TRD.
"Our single dose treatment model enables a short treatment duration which positions BPL-003 as a potentially exciting and scalable treatment opportunity," said Feilding Mellen, adding that less than 15% of patients with TRD achieve long-term remission with the current standard of care.
A randomized, quadruple-masked, controlled Phase 2b study of BPL-003 is currently underway. Its aim is to investigate the effects of a single 12mg or 8mg dose, vs. a sub-perceptual dose of 0.3mg, in 225 patients with TRD.
Efficacy will be assessed by masked raters using the MADRS scale at several time points, the primary endpoint at Week 4 and final assessment at Week 8. Topline results are expected in the second half of 2024.
"We look forward to further validating the potential of BPL-003 as a treatment option with our ongoing Phase IIb study and subsequent clinical development program," Feilding Mellen concluded.
On atai's end, CEO and co-founder Florian Brand highlighted the company's particular excitement over BLP-003's antidepressant durability potential.
"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," Brand said, to later be echoed by founder and chairman Christian Angermayer.
Separately, a Part 2 extension of Beckley's Phase 2a open-label study is now enrolling patients with TRD who are on stable doses of oral antidepressants to assess the safety and efficacy of BPL-003 co-administration.
Photo: Benzinga edit with photos by Nynke van Holten on Shutterstock and Harbin on Wikimedia Commons.
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Posted In: ATAI