Cybin’s CYB004-E Phase 1 trial evaluating DMT has completed dosing for four out of five participant cohorts.
The trial is taking place in the Netherlands at the Centre for Human Drug Research, and is Cybin’s largest Phase 1 DMT trial conducted to date.
The study is assessing the pharmacokinetics and pharmacodynamics of DMT, and the company anticipates it will provide safety and dosing data to inform the clinical development plan for CYB004 – Cybin’s proprietary deuterated DMT molecule for the potential treatment of anxiety disorders.
Cybin acquired the trial from Entheon Biomedical Corp. in July 2022, marking one of a number of strategic transactions that Cybin has completed to support its research and development pipeline of active psychedelic-based programmes and potential future novel drug candidates.
The company has stated that the acquisition of the CYB004-E Phase 1 trial replaced its planned pilot study that was expected to commence in the third quarter of 2022, and as such, has served to potentially accelerate the clinical development path of CYB004.
Cybin CEO, Doug Drysdale, commented: “The acquisition of the Phase 1 DMT study was done with an eye toward informing and accelerating the clinical path forward for CYB004 and we are very pleased with the progress so far.
“With strong intellectual property in place for this programme, the CYB004-E trial is a critical next step towards better understanding the therapeutic potential of DMT and will better inform the future development of CYB004.”
The company has confirmed that the Safety Review Committee has confirmed no clinically significant safety or tolerability issues.
The Phase 1 trial is expected to be completed in the first half of 2023.
