BPL-003 Shows Rapid Antidepressant Effect for Treatment-Resistant Depression

A new study found a single dose of BPL-003 demonstrated a rapid and durable antidepressant effect in treatment-resistant depression patients, with more than half achieving a clinical response the day after their first dose.¹

Atai Life Sciences announced on March 27, 2024, the positive results from Beckley’s Psytech’s phase 2a open-label study of BL-003 in treatment-resistant depression. Not only did investigators find BPL-003 was rapid and durable for treatment-resistant depression, but they found the drug had a good safety profile and was well-tolerated with no serious adverse events and any acute effects resolved on average in less than 2 hours.

Depression affects 280 million worldwide, and many individuals can turn to already-approved antidepressants to manage their symptoms. However, about 30% of people with depression are resistant to the current antidepressant medication. If BL-003 continues to show efficacy, durability, and safety in future trials, it can potentially serve as a new treatment option for people with depression.²

The phase 2a study evaluated a single 10 mg dose of BPL-003—a novel, synthetic, benzoate salt formulation of 5-MeO-DMT (mebufotenin) administered through the nose—along with psychological support in patients with moderate to severe treatment-resistant depression who were not taking other antidepressants.¹

The study included 11 participants who had a 10 mg dose of BL-003 and were followed for 12 weeks with several assessments throughout. The team measured efficacy through the Montgomery-Åsberg Depression Rating Scale.

Investigators found a single dose of BPL-003 provided a rapid antidepressant response in 55% of the patients the day after. BPL-003 also demonstrated durability, with a 55% response rate maintained at week 4 and continuing to week 12.

As for remission rates, the team saw there were 55% of patients in remission at week 4 and 45% in remission at week 12.

“These findings represent the longest known follow-up of depression outcomes in a clinical study of 5-MeO-DMT,” the press release stated.

BPL-003 demonstrated a good safety profile with adverse events being mild or moderate. The most common adverse events were nasal discomfort, headaches, nausea, and vomiting. On average, acute effects went away in less than 2 hours, which is a shorter time than other psychedelic treatments currently being developed.

Atai Life Sciences plans on conducting a part 2 extension of this phase 2a trial. They are now enrolling patients with treatment-resistant depression who are on stable doses of oral antidepressants to evaluate the safety and efficacy of BPL-003 alongside other antidepressants.

Furthermore, they are currently working on a randomized, quadruple-masked, controlled phase 2b study to assess the effects of a single 8 mg or 12 mg dose of BPL-002 against a dose of 0.3 mg in 225 patients with treatment-resistant depression. Investigators will use the Montgomery-Åsberg Depression Rating Scale throughout the trial to evaluate efficacy with the primary endpoint at week 4 and the final assessment at week 8. Results are expected in the second half of 2024.

“The positive data from the Phase 2a study is highly encouraging as we await the results of the larger Phase 2b study anticipated later this year,” said Florian Brand, chief executive officer and co-founder of atai Life Sciences, in the press release. “With around half of TRD patients in remission three months after just a single dose of BPL-003 in this study, we are particularly excited about its antidepressant durability potential. The results indicate that BPL-003 could offer a scalable, single-dose administration within the two hour in-clinic treatment paradigm successfully established by Spravato®.”

^References

1. ^{atai Life Sciences Announces Positive Initial Results from Beckley Psytech’s Phase 2a Open Label Study of BPL-003 (Intranasal 5-MeO-DMT) in Treatment Resistant Depression. Globe Newswire. March 27, 2024. https://www.globenewswire.com/news-release/2024/03/27/2853041/0/en/atai-Life-Sciences-Announces-Positive-Initial-Results-from-Beckley-Psytech-s-Phase-2a-Open-Label-Study-of-BPL-003-Intranasal-5-MeO-DMT-in-Treatment-Resistant-Depression.html. Accessed March 28, 2024.}
2. ^{Beckley Psytech launches Phase IIa study of lead candidate BPL-003, a novel benzoate formulation of 5-MeO-DMT, for Treatment Resistant Depression. Beckley Psytech. December 20, 2022. https://www.beckleypsytech.com/posts/beckley-psytech-launches-phase-iia-study-of-bpl-003-for-treatment-resistant-depression. Accessed March 28, 2024.}