Delix to conduct more trials after promising Phase I results

Delix Therapeutics, based in Bedford, Massachusetts, is advancing its leading neuroplastogen candidate, DLX-001, into further clinical trials targeting major depression. As revealed by Delix's Chief Medical Officer, Dr. Aaron Koenig, the company is preparing for two new studies: a Phase Ib and a Phase II trial, following the conclusion of an ongoing Phase I study.

DLX-001 is a novel neuroplastogen designed to enhance neuroplasticity without the adverse effects typically associated with first- and second-generation psychedelics. According to Dr. Koenig, the mechanism of action for DLX-001 involves a Cmax-driven effect, which essentially means that the drug activates receptors for a brief period to initiate downstream effects, rather than maintaining prolonged receptor engagement.

In May, Delix released promising Phase I data, showing that DLX-001 does not induce psychedelic experiences, such as hallucinations or dissociation, at any of the doses tested. Additionally, the treatment demonstrated a favorable safety and tolerability profile.

The upcoming Phase Ib study aims to delve deeper into the safety, tolerability, pharmacokinetics, and preliminary efficacy of DLX-001 in patients with major depression. This study will be conducted at a single site in an inpatient unit, with patient dosing expected to commence later this year. The Phase I study confirmed that DLX-001, when administered daily over a week, is well tolerated, and the maximum tolerated dose has not yet been identified.

The Phase Ib trial will be a blinded comparison between daily dosing and intermittent dosing, which will help determine the optimal dosing frequency for DLX-001 and inform the design of the Phase II study. The Phase II trial, set to begin in April 2025, will involve outpatient dosing for up to four weeks, followed by a monitoring period to evaluate the sub-acute effects of the drug on mood. This study will also assess whether the therapeutic effects of DLX-001 can be sustained after discontinuation of treatment.

The Phase II study will include three experimental arms: one with the active drug, one with a placebo, and one with a pulsatile combination of both. Each arm will consist of 30 to 40 patients. Delix aims to achieve an effect size with DLX-001 comparable to that seen with treatments like racemic ketamine or psilocybin.

Through these planned studies, Delix Therapeutics seeks to establish DLX-001 as a safe and effective treatment for major depression, potentially offering a new therapeutic option that avoids the negative side effects associated with traditional psychedelics.