New Phase 1 Data on DLX-001 for Patients With Major Depressive Disorder

Aaron Koenig, MD, the chief medical officer of Delix Therapeutics, shared phase 1 results for DLX-001, a novel neuroplastogen under development for the treatment of major depressive disorder, at the 2024 American College of Neuropsychopharmacology Annual Meeting in Phoenix, Arizona. The phase 1, 3-part study enrolled 106 healthy volunteers to assess safety, pharmacokinetics, and pharmacodynamic markers. DLX-001 demonstrated a generally safe and well-tolerated profile in healthy volunteers who received at least 1 dose of the treatment. Importantly, there was no evidence of psychotomimetic, hallucinatory, or dissociative effects, which are commonly associated with classic psychedelic treatments, at any dose level. The study also noted some effects in the brain that may hold promise for future studies of patients with depression.