First group of healthy volunteers dosed in company’s phase I trial of novel non-hallucinogenic psychoplastogen with no psychotomimetic effects
BOSTON, June 20, 2023 – Delix Therapeutics (the "Company"), a clinical-stage neuroscience company developing novel neuroplasticity-promoting therapeutics for psychiatric and neurological conditions, today announced the completion of dosing of the first cohort of subjects in its phase I clinical trial of lead candidate, DLX-001, a non-hallucinogenic psychoplastogen.
Key results from first cohort include:
● No clinically relevant adverse events or psychotomimetic effects were seen, giving the Dose Escalation Committee confidence to proceed with an assertive escalation of the dose for the second cohort.
● Close alignment of predicted pharmacokinetic (PK) with observed PK parameters in the human subjects, bolstering confidence that preclinical findings will continue to be replicated, especially with respects to timing of drug activity and clearance.
● The viability of oral administration was also confirmed in this cohort which demonstrated bioavailability and oral PK characteristics.
“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,” said Mark Rus, CEO of Delix Therapeutics. “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 I program, 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.”
Eliseo Salinas, Head of Research & Development at Delix Therapeutics, 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.”
Due to the novelty of DLX-001’s mechanism of action and the disruptive nature of this product, the first cohort of trial participants were given a low dose of DLX-001. The subjects underwent broad physiological monitoring with various biometric and cognitive readouts for seven days. Based on the totality of the data, the Dose Escalation Committee agreed to pursue a significant increase in dose for the second cohort.
The phase I trial aims to enroll approximately 100 healthy volunteers when completed, with the primary objectives of assessing safety, pharmacokinetics, psychotomimetic activity, and markers of brain activity and synaptic plasticity. The trial is currently being held at the Center for Human Drug Research (CHDR) in the Netherlands, a world-class institute specializing in cutting-edge early-stage clinical drug research. Full phase I data and readout for the trial is expected in early 2024. An Investigational New Drug (IND) application to initiate trials in the US is in preparation.
DLX-001 is the first of several psychoplastogens in Delix’s growing library of thousands of non-hallucinogenic analogs to be approved for human trials. Delix’s innovative and rigorous approach has been featured in numerous scientific publications including Nature, Cell, Science, the Journal of Medicinal Chemistry, and many more. The company has also been recognized with such awards and accolades as Fierce Biotech’s Fierce 15 list, and Nature’s Top Startups to Watch. Delix collaborates with a number scientific thought leaders, including the recently launched Institute for Psychedelics and Neurotherapeutics at the University of California Davis and the National Institute on Drug Abuse (NIDA).
This story was announced on Delix's website here: https://www.delixtherapeutics.com/news/delix-therapeutics-announces-completion-of-1st-cohort-dosing-dose-escalation-approval-in-phase-i-trial-for-novel-compound-dlx-001/