Saibin Co., Ltd. CYBN announced the launch of the first human dose of its proprietary deuterated N,N-dimethyltryptamine (DMT) molecule, CYB004, through a protocol modification of the ongoing CYB004-E Phase 1 trial, a Dutch independent ethics committee. It has been announced that it has received approval from the committee.
why it matters
This clinical advance marks the first time a deuterated DMT molecule has been evaluated in humans and further shortens Cyvin’s time to clinic with CYB004. Cybin will evaluate his CYB004 for the treatment of generalized anxiety disorder with and without major depressive disorder.
“This is a major milestone for our CYB004 program and helps us better understand the potential therapeutic benefits of our proprietary deuterated DMT molecule in the treatment of generalized anxiety disorder.” Doug Drysdale, CEO of Cybin. “The ability to evaluate new CYB004 molecules in humans at this early stage is an important achievement in clinical development, adding to what we have already learned through our DMT studies, which provide important insights into the pharmacokinetic and pharmacodynamic properties of CYB004. We expect to apply these findings to optimize the dosing and delivery of CYB004 in future clinical trials, which will provide patients with this novel investigational therapy as soon as possible. It supports our mission of
The Phase 1 CYB004-E trial, being conducted at the Center for Human Drug Research in the Netherlands, is the largest Phase 1 DMT trial ever conducted.
DMT and CYB004
In its normal form, DMT is a labile molecule that is rapidly metabolized in the body, resulting in greatly reduced bioavailability. CYB004 has the potential to overcome the limitations of DMTBased on preclinical studies, CYB004 has demonstrated improved bioavailability and pharmacokinetic profile compared to DMT when administered by intravenous and inhaled routes. These studies also demonstrate that IV CYB004 has a longer duration of effect compared to DMT, indicating the potential to extend the therapeutic window and provide better dose optimization. By maximizing CYB004 as a deuterated molecule and improving the bioavailability of DMT, CYB004 has the potential to offer a more convenient method of administration via inhalation, subcutaneous, or intramuscular routes of administration.
In February 2022, Cybin received a US composition of matter patent covering CYB004, which provides patent protection through 2041. The patent covers various deuterated forms of DMT and protects CYB004 as a putative new chemical entity.
“With our strong intellectual property and encouraging preclinical data, we are confident that there is a solid clinical development path for CYB004. We will continue to focus our research on identifying optimal routes of administration,” concludes Drysdale.