atai Life Sciences (NASDAQ:ATAI, ETR:9VC) made significant strides in advancing its innovative mental health therapies in 2023, with a focus on psychedelic-based treatments for depression.
CEO and co-founder Florian Brand joined Proactive to discuss the company’s recent milestones including encouraging clinical trial results, what to expect from its ongoing research programs and upcoming catalysts for both the company and the broader psychedelics sector.
Proactive: In 2023, there was a big focus on psychedelic-based therapies for depression. Take us through some of the milestones you achieved.
FB: 2023 was a year where we remained highly committed to developing very differentiated and novel innovative mental health therapies. The team made a tremendous amount of progress with our own program as well as some of the new programs we onboarded.
Earlier in January, we announced the strategic investment in Beckley Psytech which has two depression programs in development, BPL-003 and ELE-101. Both are psychedelic and seem to fit into that two-hour treatment window that was successfully established by Spravato (ketamine) that has been approved in 2019 by the FDA and has been proven to be effective in depression. We want to leverage the infrastructure that J&J put out with Spravato with BPL-003 and ELE-101 as well as our own DMT program which is called VLS-01.
There are a lot of good things happening in the depression space at atai. While we are also exploring some other indications, the short-duration psychedelics were indeed a core focus for us over the last month.
You’ve just announced some results from a Phase 2 trial of BPL-003. Are you encouraged by what you’re seeing?
Absolutely. It was a Phase 2, open-label trial in treatment-resistant depression. Treatment-resistant depression affects roughly a third of the depression population, so there’s more than 100 million people suffering from that type of depression where they don’t respond to available treatment options. What we’ve seen here with BPL-003, which is a 5-MeO-DMT program, is rapid-acting relief from depression and durable antidepressant effects. 45% of the patients were in remission at month three after a single dose.
If you look at depression and how it’s been historically treated, there are many SSRI antidepressants approved for at-home use, which you take chronically at home. Here, we’re looking at a therapy that after a single administration, one dose, achieved really durable effects after about three months. That’s very encouraging. As we were just talking about Spravato, what we’ve also seen here is that the acute effects of BPL-003 are resolved within an average of less than two hours, which is encouraging because it increases our conviction that it could fit into the in-clinic treatment paradigm that was successfully established by Spravato.
Where do you take the BPL-003 program from here?
We reported data from part one. There’s a part two that will look at co-administration of BPL-003 with SSRIs or antidepressants. Then, importantly, we have a large Phase 2b study going in 225 treatment-resistant depression patients. We anticipate results in the second half of this year and that will be a very exciting catalyst for the entire space of depression research and also for us at atai of course.
Touch on some of the other programs you are looking at.
In the depression space, we touched on BPL-003 or ELE-101 fitting into that two-hour window – we also want our proprietary oral transmucosal DMT formulation to fit into that two-hour in-clinic treatment paradigm that was established by Spravato. Here we also hope to achieve rapid and durable antidepressant effects.
It's pharmacologically different from BPL-003, which is 5-MeO-DMT. So even if it’s called DMT, it’s quite different from 5-MeO-DMT pharmacologically, for example, from a receptor binding perspective. If we assume it to be also clinically differentiated, we could add another tool in the psychiatrists’ toolbox.
You mentioned the Phase 2b BPL-003 program results, what other catalysts are you expecting in 2024?
Another very important one is the COMP360 Phase 3 trial readout [from Compass Pathways (NASDAQ:CMPS), in which atai has a more than 20% stake] which is guided for Q4. It is one of the most advanced trials in the psychedelic research space and is important for the overall neuropsychiatry space to see those results, and, of course, also very exciting for atai.
In addition to all the programs we discussed area, we have a very interesting and important Phase 2b trial going on in cognitive impairment associated with schizophrenia (CIS). We are testing RL-007, which is a pro-cognitive neuromodulator. It is a non-psychedelic program. We are testing this compound in the schizophrenia patient population and hope to see significant cognitive improvement in that population. It’s often very prevalent in schizophrenia patients. We anticipate having data for this trial mid-next-year.
Quotes have been edited for clarity and style