Pharma Focus Asia

Cybin Announces Approval of First-in-Human Dosing of its Proprietary DMT Molecule CYB004

Thursday, February 02, 2023

Cybin announced that it has received approval from an independent ethics committee in the Netherlands to initiate first-in-human dosing of its proprietary deuterated N,N-dimethyltryptamine (“DMT”) molecule CYB004 through a protocol amendment to its ongoing CYB004-E Phase 1 trial. This clinical advancement marks the first time a deuterated DMT molecule will be evaluated in humans and further reduces Cybin’s time-to-clinic with CYB004.

Based on preclinical studies CYB004 demonstrated superior bioavailability compared to IV DMT which supported less invasive dosing methods. CYB004 is a patented proprietary molecule protected through 2041 -

In the regular form, DMT is an unstable molecule rapidly metabolised in the body, which significantly reduces its bioavailability. CYB004 has the potential to overcome the limitations of DMT. Based on preclinical studies, CYB004 has demonstrated an improved bioavailability and pharmacokinetic profile in comparison to DMT when administered via intravenous (“IV”) and inhaled routes. These studies also demonstrated that IV CYB004 has a longer duration of effect compared to DMT, indicating the potential to extend the therapeutic window and provide better dose optimisation. By maximising CYB004 as a deuterated molecule and improving upon the bioavailability of DMT, CYB004 has the potential to offer more convenient dosing methods via inhaled, subcutaneous, or intramuscular routes of administration.

The ability to evaluate novel CYB004 molecule in humans at the early stage is a significant achievement in clinical development and will provide important insight into the pharmacokinetic and pharmacodynamic properties of CYB004 according to the earlier studies of DMT. The application of these findings to optimise dosing and delivery of CYB004 in future clinical trials, will support the mission to bring this new investigational therapy to patients as quickly as possible.

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