Canadian clinical-stage psychedelics company Cybin Inc. (CYBN) announced the dosing of its proprietary deuterated DMT molecule, CYB004, on the first group of participants in an ongoing three-part Phase 1 trial on the intravenous administration of DMT and CYB004 in healthy volunteers.
CYB004, Cybin’s promising psychedelic treatment for Generalized Anxiety Disorder (GAD), exhibits robust effects within two minutes of administration, reaching a peak at around thirteen minutes. No safety concerns were reported.
Part 3 (C) of the Phase 1 trial evaluates IV bolus plus infusion regimens of CYB004 on up to two cohorts with the data from these cohorts expected to construct a comprehensive PK/PD model toward determining optimal dosing and formulation for future trials on the proprietary drug, thus advancing Cybin’s program evaluating the CYB004 drug.
The readout of the Phase 1 trial’s safety and efficacy data is expected to be released in the third quarter of 2023.
Doug Drysdale, Cybin’s CEO, called the first-in-human dosing of CYB004, “an enormous step forward” in the clinical advancement of Cybin’s program evaluating the drug for GAD treatment. Drysdale added that the inclusion of CYB004 dosing in the Phase 1 stage accelerates Cybin’s understanding of the drug’s profile, validating its advantages for humans sooner than anticipated.
More on the Trial and CYB004
The Phase 1 trial takes place at the Centre for Human Drug Research in the Netherlands. The three-part study design evaluates escalating doses of DMT and CYB004 in healthy volunteers, assessing safety, pharmacokinetics (PK), and pharmacodynamics (PD) of both compounds.
CYB004 is a novel deuterated DMT molecule, designed to provide bioavailability improvements over existing psychedelics and offer less invasive and more convenient dosing methods. Under a U.S. patent, CYB004 is being explored as a potential treatment for GAD, either with or without Major Depressive Disorder (MDD).
Besides CYB004, Cybin’s pipeline includes CYB003, a deuterated psilocybin analog for treating MDD, for which the company will present additional topline efficacy data later this year.