atai Life Sciences (NASDAQ:ATAI, ETR:9VC) has welcomed promising initial results from Beckley Psytech’s Phase1 trial of its patient-protected intravenous (IV) formulation of psilocin ELE-101 in patients with major depressive disorder.
Beckley Psytech, a private clinical-stage biopharmaceutical company in which atai holds a 35.5% ownership stake, reported that initial data from Phase 1 single ascending dose study in healthy participants showed that ELE-101 was well-tolerated, with no serious or severe adverse events reported, and demonstrated a dose-proportional profile, which leads to reduced variability between patients when compared to oral psilocybin.
ELE-101 also induced a high-intensity, short-duration psychedelic experience which atai believes suggests a potential treatment time of approximately two hours in the clinic, enhancing convenience and therapeutic outcomes for patients with depression while reducing the resource burden on healthcare systems.
Full data from the Phase 1 study is expected to be published at a later date.
atai co-CEO Dr Srinivas Rao highlighted that the data so far on ELE-101 indicates its potential as a “promising” candidate for treating depression.
“The consistent dose delivery and dose-proportional pharmacokinetic profile are particularly encouraging, as this could reduce variability among patients,” Dr Rao said.
“At atai we are building a pipeline of short-duration psychedelics that target in-clinic treatments of approximately two hours. In addition to ELE-101, we believe Beckley Psytech’s lead candidate, BPL-003 (an intranasal 5-MeO-DMT), and our VLS-01 (an oral transmucosal formulation of DMT) could also fit this model.”
Further, Beckley Psytech has begun dosing patients in the Phase 2a part of the study, which will evaluate the safety, tolerability, subjective effects, and efficacy of a single IV dose of ELE-101 in six to 12 patients with major depressive disorder.
The dose was selected using preliminary pharmacokinetic and pharmacodynamic data from the Phase 1 part of the study. Results are anticipated in the second half of the year.
atai investors welcomed the update, boosting the stock by 3% to US$1.31 before Thursday's opening bell.