Psychedelic drug companies continue to keep investors interested, as the biotech firms report every stage of the process in drug development.
Today, Atai Life Sciences (NASDAQ: ATAI) and Cybin (NYSE: CYBN) both delivered updates to the market.
Atai Life Sciences announced the completion of the Phase 1 study of VLS-01 in healthy participants. VLS-01 is a proprietary DMT drug known for its short duration of psychedelic effect, with a serum half-life estimated at less than 10 minutes.
The drug was well-tolerated by the participants in a sublingual version versus an intravenous version of DMT (N,N-Dimethyltryptamine).
“We are pleased to report the completion of the Phase 1 study of VLS-01, in which we demonstrated a supportive PK/PD profile of our proprietary OTF formulation of DMT,” said Florian Brand, CEO and co-founder of Atai. “We plan to test a further optimized version of our OTF formulation in a forthcoming Phase 1b prior to initiating a Phase 2 study in (treatment-resistant depression).”
According to the company’s statement, the study enrolled a total of 74 healthy participants across three parts. The third part of the study evaluated VLS-01 administered and dosed as follows:
- Sublingual 80 milligrams (n=8)
- Buccal 80 milligrams with backing layer (n=10)
- Buccal 160 milligrams with backing layer (n=8).
Moving onto Phase 1b
Atai said it now plans to progress VLS-01 into a Phase 1b study in healthy participants. The study is expected to explore doses up to 160 milligrams with an optimized OTF formulation that incorporates taste masking, an intrinsic backing layer, and enhancements designed to increase permeability.
The goal of this stage is further improving the participant experience and pharmacokinetics.
The company has submitted a protocol to regulatory authorities and expects to enroll the first participant in a Phase 1b study in the first half of 2024.
Cybin Inc. announced the completion of dosing of the final cohort in its Phase 2 study of CYB003, a proprietary deuterated psilocybin analog program in development for the potential treatment of major depressive disorder (MDD). Cybin also said it expects to release topline efficacy data in the fourth quarter of this year.
“We are extremely pleased with the rapid progression we have made from initiation to completion of dosing across all cohorts in our Phase 2 CYB003 MDD study,” CEO Doug Drysdale said. “With topline efficacy data expected later this year, we are focusing on the upcoming data submission to the U.S. Food and Drug Administration and readying ourselves to scale for a potential Phase 3 pivotal study early in 2024.”
Cybin said in a statement that the study consisted of healthy volunteers who received two administrations (placebo/active and active/active) one week apart, with psychedelic effect assessed after each dose. Participants with MDD received two administrations (placebo/active and active/active) three weeks apart and response/remission was assessed three weeks after each dose.
The study is listed on ClinicalTrials.gov under Identifier: NCT05385783.
The psychedelic drug company said that the doses were well tolerated. The study will begin using capsule doses for its Phase 3 study to make it more convenient. The end of the Phase 2 meeting is expected in the first quarter of 2024, to review the Phase 3 study design.
Cybin has been focused on treatment of MDD and recently acquired Small Pharma, a company that uses a DMT drug to address MDD.