Beckley Psytech, just months away from a readout of a phase 2b trial of its psychedelic therapy for treatment-resistant depression (TRD), has built anticipation with new data showing a rapid and durable effect in an earlier-stage trial.
The results come from a phase 2a study of BPL-003, a novel formulation of 5-MeO-DMT (sometimes called mebufotenin), which is a psychoactive compound found in a wide variety of plant species, as well as the Colorado River toad.
According to Beckley, BPL-003 achieved an antidepressant response after a single intranasal dose – administered with psychological support – in 55% of patients assessed the day after dosing. The data also points to a durable effect of the treatment, with 55% of patients in remission from depression at day 29 and 45% in remission at day 85.
Importantly, the acute, psychedelic effects of the treatment were short-lived, with patients ready to be discharged after two hours. That suggests BPL-003 therapy could be scaled up relatively easily for use in health systems if it is eventually approved by regulators, and could also offer simpler administration than other psychedelics in clinical development for TRD, said Beckley.
In a statement, the company said the phase 2a findings suggest the psychedelic would fit within a new “treatment paradigm” established with the approval in 2019 of Johnson & Johnson’s Spravato (intranasal esketamine) for TRD patients who have cycled through multiple treatments without relief.
Around 280 million people are living worldwide with depression, and it is estimated that a third of them have symptoms that do not improve after first- and second-line treatment with conventional antidepressant drugs like selective serotonin reuptake inhibitors (SSRIs).
“Less than 15% of patients with [TRD] achieve long-term remission with the current standard of care,” said Cosmo Feilding Mellen, Beckley’s chief executive. “We look forward to further validating the potential of BPL-003 as a treatment option with our ongoing phase 2b study and subsequent clinical development programme.”
The phase 2b study is also testing a single administration of BPL-003 with psychological support, with two doses of the drug compared to a “sub-perceptual” dose of the compound as an active placebo control. It is enrolling 225 people with TRD who will be followed over eight weeks, with results due before the end of the year.
Other psychedelics being tested for potential in TRD include psilocybin, the psychoactive ingredient in hallucinogenic or ‘magic’ mushrooms, along with LSD, MDMA, and mescaline.
Spravato – based on a fast-acting version of ketamine – was the pathfinder for the category and after a slow start commercially brought in $689 million for J&J last year, an 84% increase on the prior year.
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