Delix Therapeutics Begins Phase 1b Trial Dosing for DLX-001 in Depression

Delix Therapeutics, a neuroscience company based in Bedford, Massachusetts, has initiated a Phase 1b clinical trial with its novel treatment, DLX-001, for Major Depressive Disorder (MDD). This study aims to evaluate the pharmacodynamics (PD), safety, tolerability, and pharmacokinetics (PK) of DLX-001, a revolutionary non-hallucinogenic neuroplastogen.

Aaron Koenig, MD, Chief Medical Officer of Delix Therapeutics, emphasized that the commencement of this clinical trial is a significant step forward in developing new treatments for MDD. The promising preclinical studies have demonstrated DLX-001’s ability to induce substantial neuroplasticity rapidly and sustained therapeutic effects in animal depression models. Dr. Koenig highlighted that prior trials have shown DLX-001 to achieve therapeutic levels with predictable PK, a good safety and tolerability profile, and no psychotomimetic, dissociative, or hallucinogenic side effects.

The Phase 1b clinical trial will involve about 20 MDD patients receiving daily oral doses of DLX-001 over a week. The primary goal is to assess the impact on translational biomarkers such as quantitative electroencephalography (qEEG), polysomnography, and other exploratory indicators. Preliminary efficacy will also be evaluated.

Delix Therapeutics is progressing quickly with its portfolio of innovative, non-hallucinogenic compounds that can be developed into scalable, orally bioavailable therapies. The company’s compounds have shown the potential for rapid and prolonged synaptic repair associated with neuropsychiatric and neurodegenerative conditions, unlike previous generations of neuroplasticity-promoting drugs such as LSD, ketamine, psilocybin, and MDMA.

DLX-001 is a unique, non-hallucinogenic, and non-dissociative isotryptamine neuroplastogen currently under investigation for MDD treatment. Preclinical research has shown that DLX-001 increases dendritic spine density in prefrontal cortex (PFC) neurons and produces quick and lasting antidepressant effects in animal models after a single dose. Recent Phase 1 data indicated that DLX-001 engages the central nervous system well and has a favorable safety and tolerability profile, with no serious adverse events reported thus far.

Neuroplastogens represent a new category of potential treatments for psychiatric and neurological conditions. These compounds promote rapid and sustained neuroplasticity in specific neural circuits, leading to fast-acting therapeutic effects. Neuroplastogens are inspired by substances beneficial across various neuropsychiatric and neurodegenerative disorders and other synaptic pathologies. Delix Therapeutics is dedicated to developing a pipeline of advanced neuroplastogens targeting the underlying mechanisms of many neuropsychiatric and neurological diseases.

Major Depressive Disorder (MDD) is a widespread and debilitating condition affecting over 280 million individuals worldwide, with 21 million sufferers in the United States alone. MDD is a leading cause of disability globally and is characterized by persistent sadness and loss of interest. Despite existing treatments, many patients do not achieve optimal responses, highlighting the need for new and improved therapeutic options.

Delix Therapeutics is committed to leveraging its innovative Neuroplastogen Platform to develop rapid-acting outpatient pharmacotherapies. The company aims to provide FDA-approved, take-home medicines to meet several unmet needs and improve the psychiatric treatment landscape for patients and healthcare providers.