atai Life Sciences (NASDAQ:ATAI, ETR:9VC) CEO and co-founder Dr Srinivas Rao talked with Proactive about the company’s clinical development progress in 2025, highlighting multiple upcoming trial readouts.
Proactive: Hello, you're watching Proactive. Joining me is atai Life Sciences CEO and co-founder Dr Srinivas Rao. Srinivas, very good to speak with you. You've had a very busy start to 2025. Let's start off with the positive topline data of part two of the Beckley Psytech’s Phase 2a trial of BPL-003. It looks pretty encouraging.
Dr Srinivas Rao: Yeah. Well, thanks for having me on. Yeah, we're very excited by that. So this is a continuation of a Phase 2a that we reported the results on last year actually. That was a single administration of BPL-003 in folks who were not taking an SSRI at that time. This is the continuation with those patients that are currently on an SSRI.
Once again, we saw very good safety and tolerability and very robust efficacy in this cohort. So certainly important data as we move forward into Phase 3 with this program. The next step here is we're waiting for the results from the large Phase 2b trial that's currently ongoing.
And if those results are as encouraging as the ones you just mentioned, when would you be expecting to go ahead with the Phase 3 trial?
I mean, we haven't officially guided on that. And of course, the reason for that is it's going to depend upon the results as well as discussions with the FDA. But generally speaking, we can anticipate something starting sometime next year — obviously, sort of middle of next year, perhaps a little later.
So you mentioned data from the Phase 2b study, which is expected in the middle of the year. Srinivas, lots of key readouts are expected this year and going into 2026. Take us through some of the other important ones.
Yeah, we've got quite a few coming up. So we have the BPL-003 Phase 2b that we were talking about now — that's mid-year. RL-007, the large Phase 2b in cognitive impairment in schizophrenia, also in the middle of this year. Sort of right on top of this one, we’ll see which one comes first.
And then early next year, the VLS-01 Illumina study that's currently ongoing should be reading out as well. We just recently initiated a Phase 2a study of EMP-01 in social anxiety disorder. That too is expected to read out in the first quarter of next year.
And you announced the dosing of the first patients in that EMP-01 trial. Srinivas, tell us more about the trial and what it’s targeted at?
Yeah, I mean again, it's an exploratory study. We wanted to go after a different indication. There's really no one focused on social anxiety disorder currently with a psychedelic compound. It’s using EMP-01, which we had reported results on in January or so last year. From our Phase 1, we found some very interesting properties of that compound — specifically that it had these antiketogenic effects like MDMA, but it also had psychedelic effects as well.
So, a really interesting profile — a blend of these two classes in many ways. We spent time looking for the appropriate indication for that and ultimately made the decision to move forward with social anxiety disorder. There is some limited data for MDMA in social anxiety disorder, particularly in the autism subset, where social anxiety disorder is quite prominent.
We are looking at broader social anxiety disorder with this. The trial broadly is a six-week study, with two administrations of EMP-01 — on day one and then at week four — and then a readout at week six. We're using a regulatory endpoint there, the so-called Liebowitz Social Anxiety Scale (LSAS).
Again, very excited to see how this drug performs in this really important patient population, one that has a huge unmet medical need — bigger than depression — and yet has very limited options, at least from the therapeutic options for the treatment.
Srinivas, apart from all of those readouts, any other milestones that your investors should be looking out for as 2025 progresses?
I think in terms of the things that people will be really focused on, those are the main ones. The readouts are obviously the key right now. Obviously, there are other readouts in the space that we're all looking at. Compass being an important one. We do remain a shareholder in Compass. They have an interim readout that is also middle of this year.
First quarter of next year, I believe, is when the totality of the so-called 005 study will read out. So again, that's going to be a big one for the space, of course.
Quotes have been lightly edited for clarity and style