Initial results from Cybin's early-phase clinical studies showcase the therapeutic potential of psilocybin- and DMT-like compounds CYB003 and CYB004.
Cybin, a Toronto-based biopharmaceutical company that aims to advance “psychedelics to therapeutics,” has shared updates on its two lead clinical development programs, CYB003 and CYB004. CYB003, a deuterated analog of the classic psychedelic drug psilocybin, is being developed as a potential treatment for Major Depressive Disorder, while CYB004, a deuterated molecule based on the classic psychedelic drug N, N-dimethyltryptamine (DMT), is being developed as a potential treatment for Generalized Anxiety Disorder.
The term “analog” refers to a chemical compound that is structurally similar to a known drug — CYB003 in the case of psilocybin, and CYB004 in the case of DMT — but has a slightly modified molecular structure. The modifications can be designed to change or improve the way the drug moves into, through, and out of the body (pharmacokinetics), to enhance its safety profile, or to improve its therapeutic effectiveness.
A deuterated molecule is a molecule that contains one or more atoms of the hydrogen isotope deuterium (also known as heavy hydrogen) in place of the more common hydrogen isotope, protium. This substitution results in a slightly heavier molecule, which can have different physical and chemical properties than the non-deuterated molecule.
In the case of psychedelics like psilocybin and dimethyltryptamine (DMT), deuterated analogs are being studied as potential therapeutic agents with potentially more efficient pharmacokinetic properties and improved efficacy compared to their non-deuterated counterparts.
Cybin’s ongoing Phase 1/2a clinical trial evaluating CYB003 has shown promising results, with participants reporting rapid and short-acting psychedelic effects with single oral doses ranging from 1 to 10 milligrams (mg). Importantly, all doses were well-tolerated, with the 8 mg and 10 mg doses showing the most meaningful and robust psychedelic effects, and no serious adverse events were reported.
These findings suggest that CYB003 is safe and well-tolerated in humans, and is capable of inducing a psychedelic response at low doses with low variability in plasma levels. Low variability in plasma levels means that levels of CYB003 in the bloodstream were consistent and predictable over time, with minimal fluctuations or changes in concentration.
Speaking to media company Business Wire, Chief Executive Officer of Cybin Doug Drysdale said “We are encouraged by the progress made in advancing our CYB003 molecule and look forward to continuing the momentum to advance this program through clinical development to bring this important treatment option to people who suffer from depression as quickly as possible.”
Cybin also shared promising updates regarding its Phase 1 clinical trial for CYB004-E, which is focused on investigating the effects of intravenously administered DMT in healthy individuals.
Cybin has amended the protocol of its Phase 1 CYB004-E trial to include a three-part study to allow for a more robust pharmacokinetic and pharmacodynamic model for the optimization of dose selection and formulation development for future clinical studies.
Part A of the trial will consist of an intravenous DMT infusion, Part B will consist of an intravenously administered bolus dose of DMT and a DMT infusion, and Part C will consist of CYB004 administration. A bolus dose refers to a single, relatively large dose of a drug given all at once, while an infusion refers to the gradual administration of a drug over a period of time.
This three-part study will enable Cybin to initiate the first-in-human dosing of CYB004 sooner than initially forecast.
Cybin confirmed that Part A of the trial assessing intravenous DMT in healthy participants has been completed, and observed that DMT was safe and well-tolerated at the evaluated dose ranges.
The findings of these early-phase studies will enable Cybin to better understand the possible effects that CYB004 may have on patients and potentially advance the development of new treatments for Generalized Anxiety Disorder.
At this stage, dosing of CYB003 in the phase 1 study is complete, and phase 2a dosing has begun. Cybin anticipates releasing top-line results from the Phase 1/2a trial in the third quarter of 2023.
As for the CYB004-E trial, 40 participants have received a dose of DMT in Part A of the phase 1 study, while dosing in Part B is underway. The administration of CYB004 in Part C is expected to commence in the second quarter of 2023, following the conclusion of Part B. Cybin aims to provide top-line results from the completed Phase 1 CYB004-E trial by the third quarter of 2023.
It is worth noting that these results are encouraging but should still be interpreted with caution. There is still a long way to go in the development of these treatments, and more research is needed to fully understand the efficacy, safety, and potential long-term effects of these compounds.
However, it is promising to see companies like Cybin investing in psychedelic research and pushing the boundaries of what we know about the pharmacokinetics and therapeutic potential of psychedelic drugs. Cybin’s advancements have the potential to lead to the development of novel treatments for depression and anxiety, two psychological conditions that have traditionally been challenging to treat and are continually on the rise.
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