This Phase I clinical trial (n=100) will assess the safety, pharmacokinetics, psychometric functions, and markers of brain activity and synaptic plasticity of DLX-001, a non-hallucinogenic psychoplastogen developed by Delix Therapeutics.
The study will be conducted at the Center for Human Drug Research in the Netherlands, aiming to evaluate the therapeutic potential of psychoplastogens for treating psychiatric and neurological conditions. Delix’s innovative approach, led by co-founder David E. Olson, focuses on discovering non-hallucinogenic compounds that promote neuroplasticity, offering significant potential in mental health treatment. The trial marks a crucial advancement in neuroplasticity-promoting therapeutics, and is the first human trial of several psychoplastogens from Delix’s platform.
Dates and recruitment criteria are estimates until a trial is officially registered.
Trial DetailsDelix Therapeutics, a neuroscience company developing novel neuroplasticity-promoting therapeutics for psychiatric and neurological conditions, today announced the regulatory approval and initiation of recruitment of a phase I clinical trial of lead candidate, DLX-001, a non-hallucinogenic psychoplastogen. The trial will enroll approximately 100 healthy volunteers with the primary objectives of assessing safety, pharmacokinetics, psychometric functions, and markers of brain activity and synaptic plasticity at the Center for Human Drug Research (CHDR) in the Netherlands, a world-class institute specializing in cutting-edge early-stage clinical drug research. “This is an important step forward for Delix, and the field of neuroplasticity promoting therapeutics overall, marking our first human trial built upon years of significant preclinical results,” said Mark Rus, CEO of Delix Therapeutics. “With the continued rise of mental health diagnoses across the globe and a significant lack of innovative treatment options available for those suffering, we are excited about the potential of psychoplastogens — especially scaleable non-hallucinogenic compounds — to treat a variety of conditions as safe and effective take-at-home medicines.” DLX-001 is the first of several psychoplastogens in the Delix platform to be approved for human trials. Delix’s approach is based on the work of company co-founder and Chief Innovation Officer David E. Olson at the University of California, Davis, who discovered several novel psychoplastogens that have significant therapeutic potential in preclinical models, without hallucinogenic side effects inherent in first and second generation psychedelic psychoplastogens. Delix’s leading science and innovative approach has been featured in numerous scientific publications including Nature, Cell, Science, the Journal of Medicinal Chemistry, and many more. Eliseo Salinas, Head of Research & Development at Delix Therapeutics, added, “Psychoplastogens such as DLX-001 offer an opportunity to significantly evolve our thinking around treating mental health disorders at scale, with effective compounds providing rapid clinical improvements that have the potential to be safe enough to be taken at home. We look forward to continuing to assess the safety and tolerability of these compounds in this trial.” The CHDR where the trial will take place is a premier independent institution for the advancement of human clinical drug development. The institute combines innovative methods and technologies, state-of-the-art facilities, and talented, motivated researchers to help maximize success. DLX-001 emerged from Delix’s growing library of thousands of active compounds that have been shown in preclinical models to promote rapid and enduring neuroplasticity, matching or exceeding the efficacy of natural psychedelic compounds, without hallucinatory responses even at high doses.
Sponsors & CollaboratorsDelix Therapeutics
Delix Therapeutics is a drug development company focusing on novel psychedelic formulations.