Atai Life Sciences and Cybin Announce Progress in Psychedelic Drug Studies

LOS ANGELES– In a sector where every advancement is keenly watched, two significant players in the psychedelic drug industry provided the market with notable updates on their respective drug testing procedures.

Atai Life Sciences Shares Phase 1 Results

Atai Life Sciences confirmed the successful completion of its Phase 1 study concerning VLS-01, its proprietary DMT drug, which is recognized for its brief psychedelic effect – a serum half-life pegged at under 10 minutes. The results from the study indicate that the drug was well-received in its sublingual form when compared to its intravenous counterpart, showcasing a potential viable alternative for drug administration.

Florian Brand, CEO and co-founder of Atai, expressed satisfaction over the outcome. “With the Phase 1 study of VLS-01 complete, the drug has shown a promising PK/PD profile in our unique OTF formulation of DMT,” he stated. “Our focus will now shift to testing an enhanced version in a Phase 1b study, setting the stage for a subsequent Phase 2 study targeting treatment-resistant depression.”

Elaborating on the specifics, the study included 74 healthy participants in total. The varied dosages tested ranged from sublingual doses of 80 milligrams to buccal doses with an integral backing layer reaching up to 160 milligrams.

Brand further detailed the company’s next steps, revealing plans for a Phase 1b study, which will explore doses up to 160 milligrams, integrating factors like taste masking and increased permeability, all aiming at refining participant experience and drug pharmacokinetics. This study is anticipated to kick off in the first half of 2024.

Cybin Announces Completion of Phase 2 Study

Meanwhile, Cybin Inc.  declared the successful dosing of its final cohort in the Phase 2 study centered on CYB003, a distinct deuterated psilocybin analog currently being evaluated as a potential treatment for major depressive disorder (MDD).

Doug Drysdale, CEO of Cybin, expressed optimism about the strides made. “The swift progression from the start to the conclusion of dosing in our Phase 2 CYB003 MDD study is immensely encouraging,” he said. “As we await efficacy data later this year, our efforts are centered on preparing a comprehensive data submission for the U.S. Food and Drug Administration, positioning us well for a potential Phase 3 pivotal study in early 2024.”

The company confirmed that the administered doses were well-tolerated among participants. In an effort to enhance convenience, the company plans to employ capsule doses for its upcoming Phase 3 study. Furthermore, a Phase 2 wrap-up meeting is slated for the initial quarter of 2024, where the design of the Phase 3 study will be reviewed.

It’s important to note that Cybin’s core focus on MDD has been evident in its recent acquisition of Small Pharma, a firm leveraging a DMT drug to tackle the same disorder.

With these revelations, both Atai and Cybin have underscored their commitment to harnessing the potential of psychedelics in treating mental health disorders, reaffirming the growing importance of this research area in the biotech sector.