Atai Life Sciences (NASDAQ:ATAI, ETR:9VC) announced positive topline results from its Phase 2b clinical study in patients with treatment-resistant depression, and a private placement for gross proceeds of $50 million.
The clincial study, in partnership with Beckley Psytech, is evaluating BPL-003, a formulation of the psychedelic compound mebufotenin, also known as DMT, that is administered using a nasal spray.
Both 8 mg and 12 mg doses of BPL-003 showed statistically significant and clinically meaningful reductions in depressive symptoms at all time points through the eighth week, compared to a 0.3 mg active control.
Atai and Beckley Psytech plan to advance the 8mg dose into Phase 3 development following regulatory consultation with the US Food and Drug Administration and other applicable agencies in coming months.
BPL-003 was generally well tolerated. No drug-related serious adverse events or suicide-related safety signals were observed. Most patients met discharge criteria within 90 minutes post-dose.
Beckley CEO Cosmo Feilding Mellen hailed the achievement of primary and secondary endpoints in this study, and said the company is "particularly encouraged that a single 8 mg or 12 mg dose of BPL-003 showed rapid and durable efficacy results, favourable tolerability and a short time in-clinic, giving us important flexibility in optimising the design of future trials".
Dr David Feifel, emeritus professor of psychiatry at the University of California, said: "What stands out in these results is that a single administration of BPL-003 in patients with treatment-resistant depression was generally well tolerated and produced a robust antidepressant effect that emerged rapidly and was solidly sustained for at least two months.
"Notably, the acute psychedelic effects were shorter than with most other psychedelics studied clinically, suggesting potential for a quicker functional recovery for patients and a reduced need for prolonged monitoring. If a treatment with this profile were available today, it would immediately become my treatment of choice for TRD."
In a separate announcement, Atai said it had raised $50 million from the sale of over 18.26 million ordinary shares and pre-funded warrants for an additional 4.57 million shares.
The financing was co-led by Ferring Ventures and Apeiron Investment Group. Additional participation came from institutional investors including Ally Bridge Group and ADAR1.
Christian Angermayer, atai founder and chairman, said: “With this financing, atai is well-positioned to accelerate its efforts and achieve its goal of delivering new therapeutic options for individuals facing serious mental health challenges.”