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Delix Therapeutics Completes First Cohort Dosing in Phase I Trial for Novel Compound
Delix Therapeutics announced recently that it has completed dosing of the first cohort of subjects in its Phase I clinical trial of novel compound DLX-001, a non-hallucinogenic psychoplastogen.
Due to the novelty of DLX-001’s action mechanism, participants in the first cohort were given a low dose of the product, with broad physiological monitoring and various biometric and cognitive readouts for 7 days.
Results from the first dosing included the following:
- No clinically relevant adverse events or psychotomimetic effects;
- Close alignment of predicted pharmacokinetic (PK) with observed PK parameters in human subjects; and
- Viability of oral administration confirmed in the cohort, which demonstrated bioavailability and oral PK characteristics.
“The first cohort of subjects in our phase I trial of DLX-001 has showcased that the compound behaves as predicted in humans,” Eliseo Salinas, head of research and development at Delix Therapeutics, said in a news release. “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.”
Based on results of the first cohort, the study’s dose escalation committee has agreed to pursue a significant dose increase for the study’s second cohort.
Overall, the Phase I trial has been designed to enroll about 100 healthy volunteers, with primary objectives of assessing safety, pharmacokinetics, psychotomimetic activity, and markers of brain activity and synaptic plasticity. The trial is being held at the Center for Human Drug Research in the Netherlands. Full Phase I data is expected in early 2024, and an investigational new drug application to initiate trials in the United States currently is being prepared.
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