atai Life Sciences (NASDAQ:ATAI, ETR:9VC) and Beckley Psytech announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression (TRD).
The FDA’s Breakthrough Therapy designation is intended to accelerate the development of drugs for serious or life-threatening conditions where preliminary clinical evidence indicates the therapy may offer substantial improvement over existing treatments.
The designation enables enhanced collaboration with the FDA and may help accelerate development timelines and regulatory review processes.
BPL-003 is designed to provide rapid and durable antidepressant effects following a single dose, with a short in-clinic therapeutic experience.
The designation follows positive topline results from Beckley Psytech’s Phase 2b core, blinded study in patients with TRD.
In the trial, single administrations of 8 mg or 12 mg of BPL-003 produced clinically meaningful and statistically significant reductions in depressive symptoms within 24 hours, with effects maintained throughout the eight-week study period.
The study also found that most patients were considered ready for discharge 90 minutes after dosing, highlighting the potential for BPL-003 to integrate into a two-hour, in-clinic interventional psychiatry model, according to atai.
“We are now among a select group of mental health companies with clinical programs that have been recognized by the FDA with Breakthrough Therapy designations,” atai CEO Dr Srinivas Rao said in a statement.
“BPL-003 is well-positioned for Phase 3 trials which are expected to initiate in the second quarter of 2026, subject to alignment with the FDA. This is great news for patients.”
Cosmo Feilding Mellen, Beckley CEO, said the designation highlights the potential of BLP-003 to address the needs of patients who are not helped by existing therapies.
“We believe the Breakthrough Therapy designation supports the strength of our clinical data and, importantly, it will help to ensure the pivotal Phase 3 clinical program will be as expedited and efficient as possible, guided by the FDA,” Mellen said.
atai and Beckley have previously announced a planned strategic combination aimed at creating a global leader in transformative mental health therapies.
Separately, atai on Thursday also announced the commencement of a proposed registered underwritten offering of its common shares.
atai intends to use the net proceeds of the offering, together with existing cash and short-term investments, to advance clinical development of its product candidates, as well as for working capital and general corporate purposes.
The company expects to grant the underwriters a 30-day option to purchase additional shares at the public offering price, less the underwriting discount. All shares to be sold will be offered by atai.
Jefferies is acting as lead bookrunner, with Berenberg Capital Markets as passive bookrunner, and Canaccord Genuity and Oppenheimer as co-managers for the offering.