The results, which come on the heels of the FDA’s approval of J&J’s esketamine nasal spray Spravato as a monotherapy for treatment-resistant depression, could serve to further bolster a space hit hard by the rejection of Lykos’ MDMA-based PTSD therapy in August 2024.
Less than a week after the monotherapy approval of J&J’s esketamine nasal spray Spravato for treatment-resistant depression reinvigorated the psychedelics space, atai Life Sciences reported positive results from a mid-stage study of DMT-based BPL-003 in alcohol use disorder.
BPL-003 is an intranasal formulation of 5-MeO-DMT benzoate being developed by Beckley Psytech, in which atai holds a 35.5% equity interest. In the Phase IIa study, treatment with BPL-003 combined with relapse prevention cognitive behavioral therapy led to “significantly reduced” alcohol consumption over a 12-week period, according to atai. The trial consisted of 12 patients with moderate to severe alcohol use disorder (AUD).
Overall, participants saw a “marked decrease” in the mean number of alcohol units consumed daily, going from 9.3 to 2.2 units by the end of the study. Additionally, 50% of patients maintained complete abstinence for at least three months.
No serious adverse events were reported, and participants were able to be discharged within two hours of treatment, atai reported.
In a Tuesday investor note, H.C. Wainwright analysts were supportive of the data, which they called “encouraging.”
“We believe these data suggest that BPL-003 may lead to potential durable effect in this challenging indication, supporting advancement of BPL-003 in AUD,” the analysts wrote.
Atai CEO and co-founder Srinivas Rao said in a statement that the company looks forward to Phase IIb data from BPL-003 in treatment-resistant depression (TRD), which are expected in mid-2025. Just last week, the FDA approved J&J’s Spravato as the first and only monotherapy for adults with TRD. While not considered a “classic psychedelic,” Jefferies analysts wrote in a Jan. 22 investor note that “Spravato’s consistent Q/Q trajectory supports the notion psychedelics can become commercially viable for mental health.” Worldwide sales of Spravato grew by 5% to $297 million in Q4 last year compared with the same quarter in 2023, according to Jefferies.
In the same note, Jefferies analysts listed atai’s BPL-003 readout as one they were watching, along with results for Compass Pathways’ COMP360, a psylocibin treatment for depression, for which the company is expecting Phase III readouts in Q2 of this year and in the second half of 2026.
The recent momentum is a positive for the psychedelics space, which took a hit last year when the FDA rejected Lykos Therapeutics’ midomafetamine (MDMA)-assisted therapy for post-traumatic stress disorder in August.
