Cybin has announced the completion of dosing the last subject in Part B of its three-part CYB004-E Phase 1 trial evaluating intravenous (IV) DMT in healthy volunteers.
With the achievement of this milestone, Cybin has stated that it intends to initiate Part C of the study, the first-in-human dosing of its proprietary DMT molecule CYB004.
Part C will evaluate IV bolus plus infusion regimens of CYB004 in a crossover design, with results from Parts B and C expected to provide a more robust pharmacokinetic and pharmacodynamic model to optimise dose selection and formulation development for future clinical studies.
Doug Drysdale, Cybin’s Chief Executive Officer, stated: “We are pleased with the continued progress we are making with our CYB004 programme and excited to reach our next key milestone of first-in-human dosing with our novel CYB004 molecule.
“Through Part C of the trial, we will have the ability to evaluate CYB004 in humans earlier than expected and potentially demonstrate the advantages of deuteration on pharmacokinetic/pharmacodynamic parameters, enabling a less invasive and more convenient dose form that may eliminate the need for specialised and costly clinical centres for dosing.”
Cybin says it expects to report topline data from the completed Phase 1 study in the third quarter of calendar year 2023.
Part A results
Data announced from Part A, the single ascending dose portion of the study, in February 2023,
which assessed a continuous IV DMT infusion, demonstrated a dose-proportional increase in exposure and dose-related increase in behavioural measures of subjective psychedelic experience with IV DMT.
Additionally, IV DMT was well-tolerated with no safety issues and no serious adverse events within the dose range evaluated.
The PK/PD data from Part A was important in guiding dose optimisation and the study protocol for Part B with a goal of exploring flexible dosing options and a shorter treatment regimen.
Drysdale added: “Every advancement we make on our clinical path is an important accomplishment toward our plan to develop optimised delivery of CYB004, and we look forward to continuing to develop CYB004 as an improved treatment option for people suffering from generalised anxiety disorder.”
Join Cybin at PSYCH Symposium
Cybin is a sponsor for PSYCH Symposium: London 2023 which will take place on 6 July at London’s iconic British Museum.
The event will provide audiences with the opportunity to hear exclusive presentations and discussions on stage and to network with leading industry figures.
Cybin’s Chief Medical Officer, Amir Inamdar, will be speaking at the event.
Inamdar is a qualified psychiatrist and pharmaceutical physician with over 20 years of clinical and drug development experience. Previously, he has led clinical drug discovery teams as a medical director for AstraZeneca, Takeda and GlaxoSmithKline.
Get your tickets to PSYCH Symposium: www.psychsymposium.com/tickets
