Largest Phase-1 DMT Study In The Netherlands, A Collaboration Between Entheon & Cybin

Cybin Inc. CYBN CYBE announced that, through its wholly-owned subsidiary Cybin IRL Limited, It has entered into an agreement to acquire a Phase 1 N,N-dimethyltryptamine (“DMT”) study from Entheon Biomedical Corp. ENBI ENTBF to accelerate the clinical development path for CYB004, Cybin’s proprietary deuterated DMT molecule for the potential treatment of anxiety disorders.

Both companies confirmed that they will be working together in the phase 1 study addressed at testing the effects of DMT in healthy smokers. Originally named the EBRX-101 study, Cybin’s acquisition changed it to CYB004-E, as it will use the novel CYB004 compound on the 50 volunteers studied.

Cybin’s CYB004 obtained its patent from the U.S. Patent and Trademark Office in February 2022. It includes various deuterated forms of DMT and 5-MeO-DMT. Furthermore, the company has recently submitted an IND application to the FDA to begin the first human clinical trial to evaluate the effects of the company’s also new compound CYB003, a psilocybin’s analog that could work for depression treatments.

What Is Being Tested

The CYB004-E study is underway in the Netherlands, at the Centre for Human Drug Research (CHDR), a leading independent foundation specializing in innovative early-stage clinical drug research. Entheon has agreed to provide ongoing support via a consulting services agreement with Cybin for a period of 12 months following closing of the deal.

It is an adaptive, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics (“PK”) and pharmacodynamics (“PD”) of a target-controlled intravenous infusion of DMT in healthy smokers.

More specifically, the trial has four goals: to evaluate the safety of increasing doses of a single dose continuous DMT infusion over 90 minutes; to characterize the pharmacokinetics and the pharmacodynamics of a single dose DMT administered continuously over 90 minutes; and to establish the minimum DMT dosage required to produce a psychedelic effect.

The Acquisition

The study was originally driven by Entheon Biomedical Corp. ENTBF, a biotech research and development company that develops and commercializes safe and effective DMT-based psychedelic therapeutic products for treating addiction and substance use disorders.

It has now passed on to Cybin, a Canadian biopharma company focused on creating safe and effective therapeutics for patients suffering from a wide range of mental health disorders. Operational in Canada, the U.S., States, the UK, Netherlands and Ireland, they engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens.

The purchasing price was $1,000,000 (CAD). Pending the close of the acquisition, the CYB004-E study is expected to yield essential safety and dosing optimization data and will replace Cybin’s planned pilot study for CYB004 which was expected to commence in the third quarter of 2022.

"The company is happy to monetize the work completed to date and continues to support R&D targeting mental health and addiction cessation and supports the completion of the clinical work," Entheon CEO Timothy Ko said.

Cybin CEO Doug Drysdale noted, "The most precious commodity in drug development is time and acquiring this robust Phase 1 study already underway potentially accelerates the CYB004 development program by approximately nine months. The PK findings from the CYB004-E study should also help to inform the clinical path forward for this innovative and proprietary molecule.”

About the collaboration, Drysdale added, “This transaction also provides Cybin with access to a world-class research foundation and the privilege to work with the Entheon team, who offer a wealth of knowledge and expertise in this psychedelic class.”

More On Entheon’s Work

Entheon holds three divisions, Entheon RX™, which focuses on the development of therapeutic drugs, using DMT as the pharmacological benchmark; Entheon ID™, focused on identification, analysis and predictive use of EEG biomarkers and genetics in the selection and management of drug treatment; and Entheon IQ™, for the development of treatment algorithms through the analysis of patient data. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

Photo Courtesy of Mabel Ambar on Pexels.