Clinical-stage biopharmaceutical company Cybin Inc. CYBN has completed participant dosing for Part 2 of 3 of its Phase 1 study evaluating intravenous (IV) administration of proprietary DMT drug CYB004.

As the study evaluates the safety and efficacy of escalating doses of DMT and CYB004 in healthy subjects, the novel drug – a deuterated DMT molecule – will be evaluated as a potential treatment for generalized anxiety disorder (GAD) with or without major depressive disorder (MDD). )

CEO Doug Drysdale said the third part of the study, which will evaluate IV bolus plus compound infusion regimens in a crossover design, could demonstrate the benefits of decoding on PK/PD parameters and “enable a less invasive and more convenient dosage form.” potentially eliminating the need for specialized dosing centers.

Cybin expects to report top-line data from the completed Phase 1 study in Q3 2023. In particular, the results from Parts 2 (B) and 3 (C) would overall provide a more robust PK/PD model to optimize dose selection and formulation development for subsequent studies.

Part 1 (A), which evaluated a single ascending, continuous IV infusion of the psychedelic, showed a dose-proportional increase in exposure and a dose-related increase in behavioral measures of subjective psychedelic experience, in addition to safety.

These results led to the dose optimization and Part B study protocol to explore flexible dosing options and a shorter treatment regimen.

Cybin has been granted a US patent for a composition of matter covering multiple deuterated forms of DMT and CYB004 as a new chemical entity. The IP protection runs until 2041.

Photo: Benzinga edit with photo by CDC on Pexels and Jynto on Wikimedia Commons.