Delix Therapeutics completes dose study for DLX-001

During research there were not any clinically-relevant adverse events or psychotomimetic effects

Delix Therapeutics – a company developing novel neuroplasticity-promoting therapeutics – has announced that it has completed dosing among first cohort of subjects. It has taken place during the company’s phase 1 clinical trial of leading candidate, DLX-001 – a non-hallucinogenic psychoplastogen.

During research there were not any clinically-relevant adverse events or psychotomimetic effects, providing the dose escalation committee with evidence to proceed with an escalation of the dose for a second cohort.

There was also close alignment of predicted pharmacokinetic (PK) along with observed PK parameters in the human subjects, boosting the possibility that preclinical findings will continue to be replicated.

Meanwhile, the viability of oral administration was also established during the clinical trial, determining bioavailability and oral PK characteristics.

The novelty of DLX-001’s mechanism of action and the disruptive nature of the product meant that the first group of trial participants were given a low dose of DLX-001. Subsequently, the patients underwent broad physiological monitoring with various biometric and cognitive readouts for a whole week.

Eliseo Salinas, head of research and development at Delix, reflected on the results: “The first cohort of subjects in our phase 1 trial of DLX-001 has showcased that the compound behaves as predicted in humans. We are confident in the sensitivity of the trial to detect central activity without a hallucinatory response initiating a new paradigm in the treatment of depression.”

Mark Rus, chief executive officer at Delix, added: “These results represent another significant milestone, not only for this compound but for the entire Delix platform, and broader industry efforts to develop non-hallucinogenic psychoplastogens.”

He concluded: “This is an important step on our way to becoming the world’s leading neuroplasticity company. We are pleased to see promising traction for the first cohort of our phase 1 programme, and we’re looking forward to further progressing our leadership position with this, as well as our other non-hallucinogenic compounds, in the coming months and years.”

The trial is being held at the Center for Human Drug Research in the Netherlands – an institute specialising in early-stage clinical drug research. Complete phase 1 data for the trial is due to be released early next year.