Beckley psychedelic hits the target, unlocking atai merger
UK psychedelic medicines developer Beckley Psytech is preparing to take its psychedelic medicine for severe depression into a pivotal trials programme on the back of a positive phase 2b readout.
The company has trumpeted the study as a comprehensive win for BPL-003, hitting the primary and all secondary endpoints, and the positive result satisfies the main condition for Beckley's $390 million takeover by German rival atai Life Sciences that was announced last month.
To coincide with the results announcement, Nasdaq-listed atai has launched a $50 million private placement, co-led by Ferring Ventures and Apeiron Investment, that will go in part towards the costs of its clinical development programmes. Shares in the company were up around 27% on the news.
According to a joint statement from the two firms, both doses of BPL-003 (intranasal mebufotenin benzoate) in the study – 8mg and 12mg – achieved statistically significant reductions in depressive symptoms at all time points of the eight-week study compared to a 0.3 mg low-dose active control.
The psychedelic is administered in controlled circumstances, with psychological support, and the majority of patients were able to be discharged within 90 minutes of the single administration.
That "suggests BPL-003 could fit within the existing 2-hour in-clinic interventional psychiatry treatment paradigm established by Spravato," said the companies, which intend to take the 8mg dose forward into a phase 3 programme, subject to discussions with regulatory authorities.
Johnson & Johnson's Spravato (esketamine) is already approved for treatment-resistant depression (TRD) and major depressive disorder (MDD) with suicidal ideation, and achieved sales of more than $1 billion last year.
The phase 2b study involved 193 patients, which Beckley and atai said makes it the largest ever controlled study of mebufotenin (also known as 5-MeO-DMT).
The results revealed an 11.1-point reduction in depression symptoms using the widely used MADRS measure compared to baseline at the 12mg dose and a 12.1-point reduction for 8mg, with a 5.8-point reduction seen in the control group.
Both the 8mg and 12mg doses of BPL-003 showed statistically significant improvements in MADRS scores as early as one day after dosing, with effects generally maintained out to week eight, according to the update.
Cosmo Feilding Mellen – currently Beckley's chief executive, who is slated to serve as chief strategy officer of the merged company – said the results "reinforce [BPL-003's] potential to be a viable treatment option for patients and healthcare systems."
If the merger to form atai Beckley goes through as expected, shareholders in the German company, which is backed by billionaire investor and PayPal co-founder Peter Thiel, will own around 69% of the combined entity.
