Delix's Non-Hallucinogen Completes Safe Administration To First Clinical Trial Cohort

Clinical-stage biotech company Delix Therapeutics announced the initial cohort of its first-in-human Phase 1 trial assessing the safety and efficacy of a new non-hallucinogenic, MDMA and 5-MeO-DMT inspired psychoplastogen has successfully been dosed.

Taking place in the Netherlands-based CHRD with the goal of enrolling

100 volunteers, the Phase 1 trial will study DLX-001’s safety, pharmacokinetics (PK,) psychotomimetic activity and markers of brain activity and synaptic plasticity. 

The novel compound was well tolerated in the healthy volunteers, showing no psychotomimetic effects. As stated by the company, due to the novelty of its mechanism of action as well as its “disruptive nature,” the first participants were given a low dose.

Following the positive outcomes, Delix received committee approval to continue the trial with an “assertive” yet “significant” drug dose escalation for the second cohort.

Besides showing no clinically relevant adverse events nor psychotomimetic effects, outcomes reflected a close alignment with predicted pharmacokinetic (PK) parameters in terms of drug activity and clearance timings and confirmed the viability of oral administration.

The company expects to share a full study data readout in early 2024 and is currently preparing an Investigational New Drug (IND) application toward beginning trials in the US.

CEO Mark Rus says these findings represent “another significant milestone, not only for this compound but for the entire Delix platform, and broader industry efforts to develop non-hallucinogenic psychoplastogens,” and affirmed Delix’s efforts toward a leadership position in the field with DLX-001 and the company’s other compounds currently under development.

Delix's head of R&D Eliseo Salinas added: “The first cohort of subjects in our phase I 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.” 

The Massachusetts-based next-generation psychedelics company is one of the several advancing psychedelic-based compounds to tackle a wide range of conditions, with lead candidate DLX-001 targeting Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD.)

See also: Delix: Elucidating How Psychedelics Actually Induce Neuroplasticity Vs. SSRIs

Photo: Benzinga edit with photo by thebigland and luchschenF on Shutterstock and Fernanda.vargas on Wikimedia Commons.