Trial On DMT Drug For Anxiety And Depression Ends Participant Dosing, Study Results Soon Released

Clinical-stage biopharma company Cybin Inc. CYBN has completed participant dosing on the part 2 of 3 of its Phase 1 trial assessing intravenous (IV) administration of proprietary DMT drug CYB004.

While the trial evaluates safety and efficacy of escalating doses of DMT and CYB004 in healthy volunteers, the novel drug -a deuterated DMT molecule- is being assessed 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 infusion regimens of the compound in a crossover design, could demonstrate the advantages of deuteration on PK/PD parameters, “enabling a less invasive and more convenient dose form” potentially eliminating the need for specialized centers for dosing.

Cybin expects to report topline data from the completed Phase 1 study in 2023’s third quarter. Specifically, results from parts 2 (B) and 3 (C) would altogether provide a more robust PK/PD model to optimize dose selection and formulation development for following studies.

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

Those results led dose optimization and study protocol of Part B toward exploring flexible dosing options and a shorter treatment regimen.

Cybin has been granted a U.S. patent for composition of matter covering several deuterated DMT forms as well as CYB004 as a New Chemical Entity. IP protection will run through 2041.

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