Cybin Inc. (NEO:CYBN | (NYSE AMERICAN:CYBN), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics®, is pleased to announce that its CYB004-E Phase 1 trial evaluating N,N-dimethyltryptamine (“DMT”) has completed dosing for four out of five participant cohorts and The Safety Review Committee has confirmed no clinically significant safety or tolerability issues. The CYB004-E Phase 1 trial was acquired from Entheon Biomedical Corp. in July 2022.
The CYB004-E trial marks one of a number of strategic transactions that Cybin has completed in recent months to support its research and development pipeline of active psychedelic-based programs and potential future novel drug candidates. The acquisition of the CYB004-E Phase 1 trial replaced Cybin’s 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, the Company’s proprietary deuterated DMT molecule for the potential treatment of anxiety disorders.
“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 program, 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.”
Doug Drysdale, Chief Executive Officer of Cybin.
The CYB004-E trial is ongoing at the Centre for Human Drug Research in the Netherlands and is the Company’s largest Phase 1 DMT trial conducted to date. The study is assessing the pharmacokinetics and pharmacodynamics of DMT and is anticipated to provide safety and dosing data to inform the clinical development plan for CYB004. Cybin expects the Phase 1 trial to be completed in the first half of 2023.
About Cybin
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.