Cybin Inc. announced positive preclinical data from a pharmacokinetic study evaluating its proprietary deuterated dimethyltryptamine (DMT) molecule, CYB004, delivered via inhalation. Specifically, inhaled CYB004 demonstrated significant advantages over both IV DMT and inhaled DMT, including longer duration of action, and improved bioavailability. The study also demonstrated that inhaled CYB004 showed a similar onset of effect and dose profile to IV DMT.

These data may support the potential for inhalation as a viable and well-controlled delivery system of therapeutic psychedelics. Cybin is currently developing CYB004 for the treatment of anxiety disorders. Based on preclinical results, inhaled CYB004 demonstrated: Approximately 2,000% improved bioavailability compared with orally administered DMT, which is known to have limited to no oral bioavailability.

Approximately 41% improved bioavailability compared with inhaled DMT. Approximately 300% longer duration of effect when compared with IV DMT, indicating potential to extend therapeutic window. Rapid onset of effect and similar low variability equivalent to IV DMT.

The Company plans to submit a regulatory filing for a pilot study in the second quarter of 2022 and to initiate the pilot study in the third quarter of 2022. CYB004 is a new chemical entity for which a patent was issued by the U.S. Patent and Trademark Office in February 2022. The allowed claims include a range of deuterated forms of DMT and 5-MeO-DMT.

The composition of matter patent is expected to expire in 2041 before consideration of any patent term extensions. The Company also recently announced that the World Intellectual Property Organization published an international patent application covering a range of inhalation delivery methods across multiple psychedelic molecules, including inhaled CYB004, further strengthening its intellectual property portfolio of psychedelic-based programs.