Debra BorchardtAtai Life Sciences (NASDAQ: ATAI) announced that the first healthy participant has been dosed in its Phase 1b trial of VLS-01, an oral transmucosal film (OTF) formulation of N,N-dimethyltryptamine (DMT). It is a single-center, open-label study that is anticipated to enroll a total of 16 healthy participants. The participants will initially receive a single dose of IV DMT followed by 3 different doses of VLS-01, with a 28-day washout window between administrations. Atai said that top-line results for the Phase 1b study are expected in the second half of this year.
“I am delighted with the swift progress our team has made to commence dosing in the Phase 1b trial,” said Atai Co-founder and Chief Executive Officer, Florian Brand. “Our proprietary oral transmucosal formulation of DMT, VLS-01, is designed to induce a short psychedelic effect to allow for scalability and broad patient access. VLS-01 is expected to fit into an established interventional psychiatry treatment paradigm of 2 hours in the clinic and is anticipated to offer a more patient and physician-friendly experience compared to intravenous administration.”
Atai said that the Phase 1b study is designed to evaluate the relative safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an optimized OTF formulation of VLS-01, compared to intravenous (IV) DMT. Atai has said before that DMT has limited oral bioavailability and current clinical studies conducted by third parties typically involve either IV or inhaled routes of administration. The company believes that VLS-01 as an OTF formulation, is expected to provide a more convenient and acceptable route of administration.
Last month, atai named its interim Chief Financial Officer Anne Johnson as the official CFO.
