atai Life Sciences (NASDAQ:ATAI, ETR:9VC) and Beckley Psytech said Tuesday that their experimental nasal spray for depression showed promising results in a mid-stage clinical trial, bolstering hopes for a new treatment option in an area where existing therapies often fall short.
The drug, known as BPL-003, is a formulation of mebufotenin benzoate delivered through a nasal spray.
It is being tested in patients with treatment-resistant depression, a form of the illness where standard antidepressants have failed.
In the latest Phase 2a study, 13 patients received two doses two weeks apart, 8 milligrams followed by 12 milligrams.
Twelve patients were included in the final analysis. The companies said the treatment produced rapid and lasting effects, with improvements in symptoms sustained for up to three months.
The study tracked patients using the Montgomery-Asberg Depression Rating Scale, a standard tool for measuring the severity of depression.
After the first dose, patients saw an average score reduction of 13.3 points at Day 2.
A second dose deepened the effect, with the reduction growing to 19 points from baseline one week later.
By Week 12, the improvement held at 13.7 points.
Response and remission rates also improved with the second dose. One week after the initial treatment, 25% of patients no longer met criteria for depression. That figure rose to 50% at Week 8, before settling at 42% at Week 12.
Importantly, the treatment was well tolerated. The companies reported that all side effects were mild to moderate, with no serious safety concerns. Patients were ready for discharge within two hours of dosing, which the companies say supports its potential use in outpatient settings.
“These results underline BPL-003’s potential to offer a rapid, well-tolerated and durable treatment option for patients with treatment-resistant depression,” said Cosmo Feilding Mellen, chief executive of Beckley Psytech.
The findings add to results from a separate Phase 2b trial, which showed that single doses of BPL-003 could provide significant benefits. Data from an extension of that study are expected in October.
atai and Beckley Psytech plan to use the combined data to design Phase 3 studies, the final stage before regulators consider approval. They expect to begin those trials in the first half of 2026, pending discussions with the U.S. Food and Drug Administration and other agencies.
Treatment-resistant depression is estimated to affect up to half of people living with the condition, highlighting the need for new approaches.