Delix Therapeutics Announces Results from Phase 1 Trial of DLX-001 for Major Depressive Disorder
A phase 1b and Phase 2 study are up next for the novel potential MDD treatment.
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Delix Therapeutics announced full results from a phase 1 trial evaluating DLX-001, a novel neuroplastogen under development for the treatment major depressive disorder (MDD), according to a company news release.1
The results were presented at the 2024 American College of Neuropsychopharmacology (ACNP) Annual Meeting in Phoenix, Arizona. Data from 106 healthy volunteers showed no hallucinogenic, psychotomimetic, or dissociative effects and no serious adverse events. Investigators observed dose-dependent changes in resting-state quantitative electroencephalography, along with drug presence in the cerebrospinal fluid, indicating brain penetration and potential therapeutic activity.
“DLX-001 has continued to demonstrate a favorable safety and tolerability profile, with no evidence of psychotomimetic, hallucinatory, or dissociative effects,” said Aaron Koenig, MD, Chief Medical Officer of Delix Therapeutics, in a news release. “These findings, coupled with dose-dependent effects on pharmacodynamic measures, support the continued evaluation of this first-in-class neuroplastogen for psychiatric conditions such as MDD in our ongoing Phase 1b study and forthcoming Phase 2 study.”
Also at ACNP, Delix reported the nomination of a another developmental candidate, DLX-159, anorally bioavailable neuroplastogen with potential to promote rapid and enduring plasticity in key brain regions implicated in psychiatric and neurological disorders.
Reference
1. Delix presents full results from Phase 1 trial of DLX-001 at ACNP Annual Meeting. [News Release] Published December 12, 2024. https://www.delixtherapeutics.com/news/delix-presents-full-results-from-phase-1-trial/
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