atai Life Sciences (NASDAQ:ATAI, ETR:9VC) CEO Dr. Srinivas Rao joined Proactive to discuss promising results from Beckley Psytech’s Phase 2a trial for BPL-003 in alcohol use disorder. The company holds a minority stake in Beckley Psytech.
A single administration of BPL-003, combined with cognitive behavioral therapy, led to 50% of patients remaining abstinent for three months.
Looking ahead, atai Life Sciences is anticipating results from a larger Phase 2b study, evaluating a single-dose administration of BPL-003 for treatment-resistant depression.
Proactive: Hello, you’re watching Proactive. Joining me is atai Life Sciences CEO and co-founder, Dr. Srinivas Rao. Srinivas, we’re talking about atai’s strategic investment in Beckley Psytech’s Phase 2a data for BPL-003. That’s for alcohol use disorder. Tell us more about this and why it matters.
Dr. Srinivas Rao: Absolutely. First of all, thank you very much for having me on. It’s good to see you again. We’re very excited about these new results, which we announced in a press release a couple of days ago.
Alcohol use disorder is a significant unmet medical need. Around 400 million people worldwide suffer from it, and it contributes to 3 million deaths annually. It’s difficult to treat and remains a chronic condition.
These trial results were particularly interesting. It was a small study involving 12 patients in an open-label trial, meaning we didn’t have a placebo group for comparison. Patients received a single administration of BPL-003 alongside cognitive behavioral therapy, which is commonly used for this condition. The results were remarkable, 50% of patients were completely abstinent for three months. Heavy drinking days dropped from 56% to 13%, and abstinent days increased from 33% to 81%. These results are clinically meaningful and could have a real impact on patients.
What’s the next data milestone on the horizon, Srinivas?
The next milestone we’re looking forward to is the results of a larger Phase 2b study, which is currently ongoing. To clarify, BPL-003 is a 5-MeO-DMT benzoate administered intranasally, similar in delivery method to esketamine (Spravato), which is already available in the U.S. for treatment-resistant depression.
Esketamine follows an established treatment model where patients visit a clinic, receive a dose, are monitored for two hours, and then leave. However, the challenge with esketamine is that it requires frequent re-dosing.
With BPL-003, our upcoming Phase 2b trial will evaluate the effects of a single administration, compared to esketamine’s eight administrations over four weeks. This will be the largest placebo-controlled study of 5-MeO-DMT, and we’re encouraged by prior data suggesting it could be effective for treatment-resistant depression.
Can you explain the benefits of short-duration psychedelics? Why does duration matter?
It ties back to the established treatment model with Spravato. Patients visit the doctor’s office, receive their dose, stay for two hours, and leave once they are cleared. This model works, but the frequent dosing requirement reduces efficiency for both patients and providers.
At atai, we’ve been focused on short-duration psychedelics that fit within this two-hour treatment paradigm but require far less frequent dosing. BPL-003 and our internal program, VLS-01, both fall into this category. Our Phase 2b trial will assess whether a single administration of BPL-003 over four weeks is effective. We’re also evaluating VLS-01 with two administrations to see if there’s an incremental benefit.
Short-duration psychedelics could make treatment more accessible by easing the burden on patients and increasing the number of people a provider can treat. That’s why we’re excited about this approach.
Quotes have been lightly edited for clarity and style