BPL-003 showed “robust” efficacy data in treatment-resistant depression, according to analysts from Jefferies, who noted that the asset could hit peak market sales of $1 billion. The results clear the way for the asset’s late-stage development and for the completion of a proposed merger with atai Life Sciences.
Beckley Psytech’s investigational intranasal psychedelic BPL-003 significantly and meaningfully eases depressive symptoms in patients with treatment-resistant depression, according to a Phase II readout on Tuesday, potentially clearing the way for late-stage trials. The results also pass muster for the completion of a proposed merger between Beckley and atai Life Sciences that is dependent on certain “success criteria” from BPL-003’s mid-stage development.
After 29 days, patients treated with 12-mg BPL-003 saw an 11.1-point reduction from baseline in their scores on the Montgomery-Åsberg Depression Rating Scale (MADRS), a validated tool to evaluate the burden of depressive symptoms. Compared with controls, who received 0.3 mg BPL-003 and saw a 5.8-point drop in MADRS, BPL-003’s treatment effect was statistically significant, with a p-value of 0.0038. The lower dose level of 8 mg also outperformed the control treatment, achieving a 12.1-point improvement in MADRS scores.
Writing to investors on Tuesday morning, analysts at Jefferies called BPL-003’s data “robust,” emphasizing that these numbers were obtained after just a single dose of the investigational drug. Jefferies also noted the durability of the nasal spray’s benefits out to eight weeks. According to Tuesday’s release, the 8-mg and 12-mg doses were able to maintain 10.8-point and 10.2-point improvements in MADRS scores through 57 days. Over the same time span, the control group saw a 5.2-point reduction in scores.
Tuesday’s readout “strengthens the notion psychedelics can safely produce profound efficacy for tough . . . CNS disorders,” the analysts wrote, adding that they estimate peak sales for BPL-003 to hit $1 billion.
Beckley, a private U.K. company, is currently in the process of merging with Berlin-based atai, in a deal announced in early June. That deal is contingent on certain “success criteria” from BPL-003’s mid-stage development—though the companies said on Tuesday that both the reported safety and efficacy outcomes meet the merger conditions. Atai jumped as high as 15% in premarket trading on Tuesday.
Beckley and atai expect to share additional data from this mid-stage study at a future scientific congress. The partners will also meet with the FDA in coming months to align on a Phase III study design for BPL-003.
BPL-003 was well-tolerated at all doses, with nearly all treatment-emergent adverse events being mild or moderate in severity. There were no serious adverse events linked to the study drug. Importantly, there were no cases of suicidal intent or behaviors.
BPL-003 is an intranasally formulated version of mebufotenin benzoate, a tryptamine psychedelic. Atai and Beckley will potentially sail smooth waters when advancing BPL-003, particularly as “sentiment in psychedelics may be improving with a friendlier administration,” according to the Jefferies note on Tuesday. Both HHS Secretary Robert F. Kennedy and FDA Commissioner Marty Makary have publicly declared support for using psychedelics in neuropsychiatric conditions.
