AtaiBeckley Inc. (NASDAQ: ATAI) has completed dosing the last patient in its Elumina Phase 2b clinical trial, which evaluates VLS-01 for treatment-resistant depression (TRD).
This international, multi-center, double-blind, randomized, placebo-controlled study involves 156 patients, with results expected in the fourth quarter of 2026.
The company plans to advance VLS-01 into a Phase 3 program for major depressive disorder (MDD) if the Phase 2 results are favorable.
TRD and MDD share significant clinical similarities, and success in TRD could support further development for MDD.
AtaiBeckley is also considering generalized anxiety disorder (GAD) as a potential indication for VLS-01, citing the drug’s serotonergic mechanism and the high unmet need in this area.
Srinivas Rao, Co-Founder and Chief Executive Officer at AtaiBeckley, said, “Completing enrollment and dosing the last patient in Elumina keeps us on track for an anticipated topline readout in Q4 2026 and marks the strategic moment to articulate where this program goes next.”
