Cybin Inc. (NEO:CYBN | NYSE American:CYBN), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics ® today announced significant progress updates for its two lead clinical development programs: CYB003, its proprietary deuterated psilocybin analog for the potential treatment of Major Depressive Disorder and CYB004, its proprietary deuterated N,N-dimethyltryptamine molecule being developed for the potential treatment of Generalized Anxiety Disorder. In connection with today’s announcement, Cybin will host an R&D Day today, February 28, 2023, at 10:00am ET. To register for the virtual event, click here .
Interim findings from the Company’s ongoing Phase 1/2a clinical trial evaluating CYB003 demonstrated positive observations, including a rapid and short-acting psychedelic response in participants. Participants received single oral doses of CYB003 at 1 milligram (“mg”), 3mg, 8mg, and 10mg, respectively, and all doses were well-tolerated with no serious adverse events reported. Most notably, participants reported meaningful and robust psychedelic effects at the 8mg and 10mg doses, confirming a complete mystical experience was achieved. These interim findings demonstrate that CYB003 was rapid and short acting, had low variability in plasma levels, and reached a psychedelic effect at low doses, while maintaining a safe and well-tolerated therapeutic profile. As of the date of this press release, Phase 1 dosing has been completed and the Phase 2a portion of the trial has commenced. Cybin expects to report top-line results from the completed Phase 1/2a clinical trial in late third quarter of calendar year 2023.
Doug Drysdale, Chief Executive Officer of Cybin
“It is incredibly gratifying that our findings from the interim readout of the CYB003 Phase 1/2a clinical trial align with the results observed in preclinical studies. Robust psychedelic effects were observed at low doses, absorption was rapid with low variability, and effects were short lasting – all desired outcomes. These findings give us confidence in the potential efficacy of the underlying active agent, which may ultimately reduce symptoms of depression after just one or two doses. This would be a remarkable improvement over chronic treatments that are available today. 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.”
The Company today also provided an update on its Phase 1 CYB004-E trial evaluating intravenous N,N-dimethyltryptamine (“IV DMT”) in healthy volunteers. Per a protocol amendment to the initial trial design, Cybin has established a three-part study to include Part A (IV DMT infusion), Part B (IV DMT bolus + infusion) and Part C (CYB004) in healthy volunteers, which will allow the Company to initiate first-in-human dosing of CYB004 sooner than initially planned. Data from the new Parts B and C of the trial will serve to build a more robust pharmacokinetic (“PK”) and pharmacodynamic (“PD”) model to optimize dose selection and formulation development for future clinical studies. The Company confirmed today that Part A of the trial evaluating DMT IV in participants is now complete, and IV DMT at the evaluated dose ranges was demonstrated to be safe and well-tolerated. As of the date of this press release, the Phase 1 CYB004-E trial has dosed 40 participants in Part A and dosing has commenced in Part B. Dosing of CYB004 in Part C is expected to begin in early Q2 2023, following the completion of Part B. Cybin expects to report top-line results from the completed Phase 1 CYB004-E clinical trial in the third quarter of calendar year 2023.
“Our CYB004 program has made significant progress marked by confirmatory results from Part A of the Phase 1 CYB004-E trial and the acceleration of first-in-human dosing of CYB004,” continued Drysdale. “Recent protocol amendments will allow us to further evaluate CYB004 and demonstrate the advantages of deuteration on PK and PD parameters. We see the potential for short duration treatments, which could truly transform the treatment paradigm and outcomes for patients. As well, we believe that deuteration may support less invasive and more convenient dosing methods for providers and patients.”
R&D Day to be held today February 28, 2023, at 10:00 a.m. ET.
Cybin’s leadership team is hosting a virtual R&D Day event today, featuring key opinion leader Dr. Maurizio Fava, Psychiatrist-in-Chief of Massachusetts General Hospital (“MGH”), Vice Chair of the MGH Executive Committee on Research, Executive Director of the Clinical Trials Network and Institute at MGH, Associate Dean for clinical and translational research, and the Slater Family Professor of Psychiatry at Harvard Medical School. The Company will provide further information on the interim readout from its ongoing CYB003 Phase 1/2a trial and additional updates on its CYB004 program. Click here to register for the event.
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.