atai Life Sciences (NASDAQ:ATAI, ETR:9VC) recently welcomed encouraging results from Beckley Pystech’s Phase 1 trial of its patient-protected intravenous (IV) formulation of psilocin ELE-101 in patients with major depressive disorder.
The company owned a 35.5% stake in Beckley Psytech.
atai co-founder and CEO Florian Brand joined Proactive to discuss the results, highlighting that in the trial, ELE-101 was well tolerated with no serious safety concerns and a predictable dose-proportional pharmacokinetic profile.
Proactive. Tell us a bit about ELE-101, what it does, and how does it differ from psilocybin?
Florian Brand: I'm very happy to walk you through the rationale for ELE-101. It's basically an IV formulation of psilocin, the active metabolite of psilocybin. Psilocybin is always turned into psilocin when broken down in the body. We are developing an IV formulation of psilocin for depression.
If you look at psychedelics, especially the first-generation compounds in development like psilocybin or LSD, they have quite a long treatment duration and need to be administered in a clinical setting. Those sessions can last up to 12 hours for LSD and around six hours for psilocybin. We aim to improve that by reducing the treatment window to approximately two hours, which we believe provides greater convenience for patients and reduces the resource burden on the healthcare system. Additionally, the IV psilocin formulation, ELE-101, aims to have a better predictable and less variable profile, reducing inter-patient variability of the drug.
What do the Phase 1 results tell us?
In Phase 1 with healthy participants, ELE-101 was well tolerated with no serious safety concerns. This was very encouraging before moving into Phase 2 and to inform dose selection. We observed a dose-proportional pharmacokinetic profile, meaning drug levels in the body were predictable with increased doses. This helped inform dose selection, and data supports the shorter two-hour treatment duration in the clinic.
What's next for ELE-101?
We dosed the first patient in the Phase 2a study, a small 6 to 12 patient study. We anticipate data in H2 of this year and look forward to initial efficacy reads in a small patient cohort.
Can you tell us more about the two-hour treatment paradigm and other assets targeting this timeframe?
Absolutely. We have ongoing trials investigating first-generation psychedelics in different neuropsychiatric indications like depression and anxiety. We have supported psilocybin's development and maintain an ownership stake in Compass Pathways (NASDAQ:CMPS), developing psilocybin therapy with COMP360. They are guiding for Phase 3 data in Q4 this year. Early approvals of treatments like spravato, an intranasal esketamine spray, established the two-hour clinic treatment paradigm. We aim to leverage this for scalable and accessible depression treatments.
Additionally, we have BPL-003, an intranasal formulation of 5-MeO-DMT, and VLS-01, an oral transmucosal formulation of DMT, both intended for depression. We are excited about the potential of short-duration paradigms for psychiatric interventions.
Quotes have been edited for clarity and style