Cybin provides updates on CYB003, CYB004 programs

Cybin announced 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 the announcement, Cybin will host an R&D Day. Interim findings from the company’s ongoing Phase 1/2a clinical trial evaluating CYB003 demonstrated observations, including a rapid and short-acting psychedelic response in participants. Participants received single oral doses of CYB003 at 1 milligram, 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. The company also provided an update on its Phase 1 CYB004-E trial evaluating intravenous N,N-dimethyltryptamine in healthy volunteers. Per a protocol amendment to the initial trial design, Cybin has established a three-part study to include Part A, Part B and Part C 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 and pharmacodynamic model to optimize dose selection and formulation development for future clinical studies. The company confirmed 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.