-Cybin Inc. (NEO:CYBN / NYSE American: CYBN), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, today announced that the first participants have been dosed with CYB004 in its ongoing three-part Phase 1 clinical trial evaluating intravenous N,N-dimethyltryptamine (“IV DMT”) and CYB004 in healthy volunteers. As expected, robust psychedelic effects were seen within two minutes, reaching a peak at about thirteen minutes. No safety concerns were reported from these initial participants.
Doug Drysdale, Chief Executive Officer of Cybin
“The first-in-human dosing of CYB004 represents an enormous step forward in the clinical advancement of our program evaluating this innovative compound for the potential treatment of Generalized Anxiety Disorder. The inclusion of CYB004 dosing in our Phase 1 trial affords us the opportunity to better understand the PK/PD profile of CYB004 and validate the advantages of this proprietary molecule in humans earlier than expected. We plan to leverage these findings to support our goal of developing a differentiated psychedelic-based therapeutic with an optimal treatment profile that may offer less invasive and more convenient dosing methods to provide new and improved treatment options for patients and providers.”
Part C of the Phase 1 CYB004-E trial is a crossover study design which will evaluate IV bolus + infusion regimens of CYB004 in up to two cohorts. Data from Part C and the completed Part B portion of the Phase 1 study are expected to provide a comprehensive PK and PD model that will be used to determine optimal dosing and formulation for future clinical trials of CYB004. The Company anticipates a topline data readout from the Phase 1 trial in the third quarter of calendar year 2023.
“We are proud of the speed in which we have advanced this CYB004 program and look forward to sharing topline results later this year, along with additional topline efficacy data from our lead clinical program, CYB003, which is currently being studied in patients with Major Depressive Disorder,” concluded Drysdale.
About the CYB004-E Phase 1 Trial
The Phase 1 trial is a three-part study evaluating the safety, pharmacokinetics, and pharmacodynamics of escalating doses of DMT and CYB004 in healthy volunteers. The three-part study design was established in a protocol amendment to the initial study design, allowing the Company to initiate first-in-human dosing of CYB004 sooner than initially planned. The CYB004-E study is being conducted at the Centre for Human Drug Research in the Netherlands and is one of the largest Phase 1 DMT clinical trials to date.
CYB004 is a proprietary deuterated DMT molecule. DMT has been shown to exert its psychedelic effects by activating the 5-HT2A receptor. In its regular form, DMT is an unstable molecule rapidly metabolized in the body, which significantly reduces its bioavailability. By maximizing CYB004 as a deuterated molecule and improving upon the bioavailability of DMT, CYB004 has the potential to overcome existing limitations of DMT and offer less invasive and more convenient dosing methods.
CYB004 is being evaluated as a potential treatment for Generalized Anxiety Disorder with or without Major Depressive Disorder. CYB004 is secured by a U.S. composition of matter patent with protection through 2041. The patent covers a range of deuteration forms of DMT and protects CYB004 as a putative new chemical entity.
Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.
Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The Company is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.