Cybin has completed the previously announced acquisition of a Phase I N,N-dimethyltryptamine (DMT) study of anxiety disorder treatment from Entheon Biomedical.
Claimed to be the largest to date, the DMT study is expected to expedite the clinical development path of Cybin’s deuterated DMT molecule, CYB004, to treat anxiety disorders, by about nine months.
The study, which is now named as CYB004-E, is being conducted in 50 healthy tobacco smokers in the Netherlands at the Centre for Human Drug Research.
Cybin announced the acquisition of the study last month, through its fully owned subsidiary Cybin IRL.
It is a randomised, placebo-controlled, double-blind, adaptive, single ascending dose trial which has been designed for assessing pharmacokinetics (PK), pharmacodynamics (PD), and safety of a target-controlled intravenous infusion of DMT in healthy smokers.
The trial’s primary objectives include evaluation of the safety of increasing doses of a single dose continuous DMT infusion over 90 minutes and establishment of the minimum DMT dose that is required for producing a psychedelic effect.
The PK and PD of a single dose DMT administered continuously over 90 minutes will also be characterised as primary objectives of the trial.
Cybin CEO Doug Drysdale said: “With the closing of this transaction we are well on our way to advancing CYB004 through Phase I development and gathering essential safety and dosing optimization data that will inform the clinical path forward for this important molecule.
“Cybin now has multiple clinical-stage programmes ongoing that we believe will contribute significantly to a greater understanding of the potential of psychedelics to provide therapeutic relief to patients who suffer with a variety of mental health issues.”
The company has paid $769,637 (C$1,000,000) as purchase price for the acquisition.
After completion of the deal, Entheon will provide up to $369,426 (C$480,000) additional amount for consulting services for up to 12 months.
Cybin IRL has also signed a data license agreement with Entheon enabling the latter to obtain access to certain data for supporting the Entheon IQ programme.