Cybin Inc. (NYSE: CYBN) announced that it has received approval from an independent ethics committee in the Netherlands to begin the first in-human dosing of its proprietary deuterated N, N-dimethyltryptamine (DMT) molecule CYB004 through a protocol amendment to its ongoing CYB004-E Phase 1 trial.
Why It Matters
This clinical advancement marks the first time a deuterated DMT molecule will be evaluated in humans and further reduces Cybin's time-to-clinic with CYB004. Cybin plans to evaluate CYB004 for the treatment of generalized anxiety disorder with or without major depressive disorder.
"This is a major milestone for our CYB004 program and for better understanding the potential therapeutic benefits of our proprietary deuterated DMT molecule for the treatment of generalized anxiety disorder," said Doug Drysdale, Cybin's CEO. "The ability to evaluate our novel CYB004 molecule in humans at this early stage is a significant achievement in clinical development and will provide important insight into the pharmacokinetic and pharmacodynamic properties of CYB004 in addition to what we have already learned through our study of DMT. We expect to apply these findings to optimize dosing and delivery of CYB004 in future clinical trials, which supports our mission to bring this new investigational therapy to patients as quickly as possible."
The Phase 1 CYB004-E trial is being conducted at the Centre for Human Drug Research in the Netherlands and is the largest-ever Phase 1 DMT trial conducted to date.
DMT And CYB004
In its regular form, DMT is an unstable molecule rapidly metabolized in the body, which significantly reduces its bioavailability. CYB004 has the potential to overcome the limitations of DMT. Based on preclinical studies, CYB004 has demonstrated an improved bioavailability and pharmacokinetic profile in comparison to DMT when administered via intravenous and inhaled routes. These studies also demonstrated 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 upon the bioavailability of DMT, CYB004 has the potential to offer more convenient dosing methods via inhaled, subcutaneous, or intramuscular routes of administration.
In February 2022, Cybin secured a U.S. composition of matter patent covering CYB004, which provides patent protection through 2041. The patent covers a range of deuterated forms of DMT and protects CYB004 as a putative new chemical entity.
"With strong intellectual property in place and promising preclinical data, we believe we have a solid clinical development path forward for CYB004. We will continue to focus our research on identifying the most convenient routes of administration while also maintaining an optimal therapeutic profile for this important molecule," concluded Drysdale.