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Beckley and atai Leadership Unpack Phase 2b Data, Take Aim at GH’s Dosing Model

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Beckley and atai Leadership Unpack Phase 2b Data, Take Aim at GH’s Dosing Model

This morning, executives from Beckley Psytech and atai Life Sciences hosted a conference call to discuss the topline results from their Phase 2b study of intranasal 5-MeO-DMT (BPL-003) for treatment-resistant depression (TRD).

On the call, atai CEO Srini Rao said that the results “exceeded all our expectations”, and Beckley CEO Cosmo Feilding-Mellen went on to share his excitement around the findings.

Beckley Chief Science and Medical Officer Rob Conley then presented the data, which included various additional colour to what was shared in this morning’s press release and our Breaking News reporting. While we touched on many of the topics discussed on the call in our Interview with Feilding-Mellen and Conley, the call provided a first look at aspects like baseline participant characteristics, responder and remission rates, and a more detailed view of adverse events.

For that reason, we’re penning this quick update to share some of that new information.

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As alluded to, Conley shared baseline characteristics of the trial population, which are useful for assessing the clinical significance of the antidepressant effect and important data to have in hand when comparing trials to one another:

Patient Characteristics - BPL-003 Phase 2b

With an average baseline MADRS score of 31.8, the study’s patient population was slightly more severe than GH’s (which had a baseline of 29 in the active arm and 28.2 in the placebo).

That’s something that atai CMO Kevin Craig picked up on later in the call, where he reiterated that GH’s baseline MADRS was a little lower, and the average duration of the current depressive episode ‘significantly shorter’ (around 2.5 years in Beckley’s Phase 2b, vs. around 13 months in GH’s).

All-in-all, Craig believes Beckley had a more difficult-to-treat group of patients than GH, adding to the list of reasons why the BPL-003 day 8 MADRS (the latest possible blinded endpoint to compare) reduction was less than GH001.

We also got a better look at the adverse event profile across the three doses...

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