Delix Therapeutics, a neuroscience company based in Boston Massachusetts, has received approval for a Phase I clinical trial examining its novel non-hallucinogenic psychoplastogen drug DLX-001.
The company announced the regulatory approval for the study on Tuesday and plans to enroll 100 healthy volunteers in the trial at the Center for Human Drug Research in the Netherlands.
The main objectives of the trial will be to assess the compound’s safety, pharmacokinetics, psychometric functions, synaptic plasticity and markers of brain activity. The company has not specified when the trial will begin.
BIG NEWS! @Delix_tx just started clinical trials with the first novel nonhallucinogenic #psychoplastogen! Congrats to Delix and to all the @DEOlsonLab and @UCDavisIPN members who made this possible. Very rare for an academic idea to get to the clinic!https://t.co/PFoc2v7ZoA
— Olson Lab (@DEOlsonLab) May 9, 2023
Psychoplastogens are a class of compounds that have the potential to promote neuroplasticity in the brain as many psychedelics do with similar properties but are specifically designed to enhance brain function without inducing psychoactive effects or altered consciousness in users.
DLX-001 is the first approved psychoplastogen from Delix’s platform, based on the work of the company’s co-founder David E. Olson.
His research at the University of California, Davis, led to the discovery of psychoplastogens with significant therapeutic potential in preclinical models.
UC Davis established an Institute for Psychedelics and Neurotherapeutics in February with the intention of advancing safe and effective treatments for diseases such as depression, Parkinson’s, PTSD, substance use disorders and Alzheimer’s.
DLX-001 is a compound from Delix’s extensive library of active compounds that are said to promote enduring neuroplasticity, with efficacy comparable to or better than natural psychedelic compounds. Unlike the natural compounds, DLX-001 is not psychoactive, even at high doses, which Delix says is evidenced by preclinical models.
“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,” said Delix’s CEO Mark Rus, adding that this first in-human trial is the result of years of preclinical studies and results.
Delix was recognized as a leading start-up company in September last year by the renowned scientific journal Nature Biotechnology.
The company has established a substantial private investor base comprised of firms such as RA Capital, Artis Ventures and Dolby Family Ventures.