Canadian clinical-stage psychedelics company Cybin Inc. (NYSE:CYBN) announced that the first group of participants have been dosed with its proprietary deuterated DMT molecule, CYB004, in an ongoing three-part Phase 1 trial evaluating both intravenous DMT and CYB004 in healthy volunteers.
CYB004’s robust psychedelic effects were seen within two minutes of administration, reaching a peak at about thirteen minutes. No safety concerns were reported from the dosed group.
Part 3 (C) of the Phase 1 trial has a crossover design set to evaluate IV bolus plus infusion regimens of CYB004 in up to two cohorts. Together with completed Part B, they are expected to provide a comprehensive PK/PD model toward determining optimal dosing and formulation for following trials on the proprietary drug.
Cybin anticipates a safety and efficacy data readout from the full Phase 1 trial in 2023’s third quarter.
CEO Doug Drysdale says the first-in-human dosing of CYB004 represents “an enormous step forward” in the clinical advancement of Cybin’s program evaluating the drug for the treatment of Generalized Anxiety Disorder (GAD). He added that the inclusion of CYB004 dosing in the Phase 1 stage will help the company better understand the drug profile and validate its advantages for humans earlier than expected.
“We plan to leverage these findings to support our goal of developing a differentiated psychedelic-based therapeutic with an optimal treatment profile that may offer less invasive and more convenient dosing methods to provide new and improved treatment options for patients and providers,” Drysdale stated.
More On The Trial And CYB004
Conducted at the Centre for Human Drug Research in the Netherlands, the Phase 1 trial is a three-part study evaluating safety, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating doses of DMT and CYB004 in healthy volunteers.
The three-part study design was established in a protocol amendment to its original design, allowing Cybin to commence first-in-human dosing of CYB004 sooner than initially planned.
CYB004 is a novel deuterated DMT molecule designed to improve the original psychedelic’s bioavailability profile, overcoming its existing limitations and offering less invasive and more convenient dosing methods.
The compound is being assessed as a potential treatment for GAD either with or without Major Depressive Disorder (MDD,) with the composition of matter IP covered by a U.S. patent all through 2041.
Cybin’s other molecule under development is CYB003, a deuterated psilocybin analog for the potential treatment of MDD, about which CEO Drysdale says the company will present additional topline efficacy data later this year.
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