Psychedelic Alpha’s Josh Hardman sat down with Beckley Psytech CEO Cosmo Feilding-Mellen and Chief Scientific and Medical Officer Rob Conley to discuss today’s topline results from the company’s Phase 2b trial of intranasal 5-MeO-DMT (BPL-003) in treatment-resistant depression (TRD).
Before you dive into this interview, be sure to read our headline coverage of the results: BREAKING: Beckley’s 5-MeO-DMT Shows Rapid, Durable Antidepressant Effects in Phase 2b Study.
Even though it has been edited for length and clarity, this is still quite a lengthy interview. We have added subheadings for easier navigation.
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In this Interview
- 8 mg: the Goldilocks dose?
- Is the mystical experience essential?
- Phase 3 study design; ineffability; blinding integrity
- Comparisons to GH Research’s Phase 2b; expectations around a second dose
- Psychological support across Beckley and GH’s studies
- Smaller 8 mg arm; psychedelic naiveté
- How often might patients need BPL-003?
- Monotherapy or adjunctive?
- A faster path to approval under Trump?
- IP position
- Final thoughts
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8 mg: the Goldilocks dose?
Josh Hardman, Psychedelic Alpha: Were you surprised that the 8 mg dose performed better than 12 mg?
Rob Conley, Chief Scientific and Medical Officer, Beckley Psytech: Honestly, Josh, I was not all that surprised. We know that 12 mg probably gives you a little more of a psychedelic experience, but I know that the receptors in the brain are occupied almost about the same at 8 mg as 12 mg.
There’s some slight differences in intensity, but as far as the whole prolonging of effect and everything, I thought there was a good chance that 8 mg would be as much. So I expected 8 mg to be maybe 90% of what 12 was; I wasn’t expecting them to be the same, so I was a little bit surprised.
Cosmo Feilding-Mellen, Chief Executive Officer, Beckley Psytech: What we were trying to do with this study was to really characterise the efficacy of a single dose. It’s really the first study that properly looks at the durability of effect as well as the effect, characterising a single dose and a dose range of 5-MeO-DMT, and arguably any short duration psychedelic.
Based on our Phase 1 and Phase 2a data—because there’s not much clinical data on 5-MeO-DMT—we wanted to give ourselves two proper shots at getting an effective and well-tolerated dose. We wanted a chance that they separate, as well, but we were giving ourselves two shots, rather than just looking for a medium dose that was going to not show efficacy.
So we are really delighted that 8 mg is showing similar efficacy and a better tolerability profile. As Rob would say, as the expert here, if you can get similar efficacy with less drug, that’s a wonderful outcome.
Is the mystical experience essential?
Hardman: Looking back at some of your Phase 1 data (e.g., Rucker et al., 2024), it seems to suggest that the 8 mg dose did not reliably lead to a full mystical experience, at least according to the Mystical Experience Questionnaire (MEQ) findings. So, does the success of that dose in this study change your thinking around the potential mechanism of action?
Feilding-Mellen: We’ve got to analyze that data more carefully. We’ve only got the top line data that we’re announcing at the moment.
I think it’ll be really interesting to see how similar or different they are on the [Mystical Experience Questionnaire]. We still believe that 8 mg will induce a profound subjective effect; I think we’re pretty confident that that’s the case.
I think we’ve always thought that MEQ is kind of directionally useful, but that’s as far as it goes.
Conley: In our earlier data we found an interesting thing across both the 5-MeO-DMT and the psilocin program: It appeared that the thing that was associated with a good clinical benefit was the ineffability subdomain of the MEQ.
I always thought it was a weird thing to begin with. How does somebody rate themselves on a scale of 1 to 10 about something that can’t be rated!? But the reality is, people do say, ‘Something strange has happened to me’, and those scores seem to max out between 8 and 12.
So, yes, I do think 12 mg is doing a little more in the psychedelic domain, but what we might find is that there are parts of the MEQ, which was really designed to rate psychedelic experiences as opposed to depression outcomes, that are more predictive of depression outcomes than others. That would be new news…
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