Cybin Inc. announced positive safety, pharmacokinetic (?PK?) and pharmacodynamic (?PD?) data from its Phase 1 studies of CYB004 (IV) and SPL028 (IV and IM) in healthy volunteers. CYB004 and SPL028 are proprietary deuterated DMT molecules within the Company?s DMT program in development for the treatment of generalized anxiety disorder. Results from the Phase 1 studies in the CYB004 and SPL028 programs demonstrated PK and PD profiles with the potential to bridge data across these molecules, and the PK profiles for both molecules demonstrated concentrations in the effective range.

Both IV (CYB004 and SPL028) and IM (SPL028) administration routes were safe and well-tolerated, with potential for IM dosing to provide a more convenient dosing method for patients when compared to IV infusion. IM dosing of SPL028 produced robust psychedelic effects lasting a short duration in the majority of subjects, a finding that supports IM administration as a well-tolerated and effective dosing method that is highly scalable. Phase 1 CYB004 Topline Results: The objective of the Phase 1 CYB004 study was to evaluate the safety, PK, and PD of escalating doses of DMT and CYB004 in healthy participants.

This was a three-part study, consisting of Part A (90-minute IV DMT infusion) in 39 participants, Part B (IV DMT bolus + infusion) in 12 participants, and Part C (IV CYB004 bolus ± infusion) in 24 participants. CYB004 was well-tolerated with no serious adverse events, and the majority of adverse events were mild to moderate and self-limiting. The Phase 1 study?s robust dataset on safety, tolerability and PK/PD provided important dosing information allowing the Company to advance its deuterated DMT program into patients in a Phase 2 GAD study in First Quarter 2024.

Study highlights: Escalating doses of DMT IV infusion over 90 minutes were well-tolerated. Robust psychedelic effects were produced, and the intensity of effects was related to the rate at which the peak concentration was achieved. Deuteration of DMT, as with CYB004, resulted in stronger psychedelic effects at lower plasma concentrations, compared with native DMT.

These psychedelic effects were rapid in onset when administered as an IV bolus over 5 minutes and persisted for about 40 minutes after the bolus without the need for an extended infusion. This short duration of effects has the potential for CYB004 to be a scalable treatment that can be delivered in a shorter period of time compared with longer acting psychedelics. Phase 1 IV/IM SPL028 Topline Results: The Company also announced the completion of dosing in a Phase 1 study evaluating IV and IM doses of SPL028 (deuterated DMT) in healthy participants.

The objective of this study was to evaluate the safety, PK, and PD of escalating doses of SPL028 in healthy participants. This was a two-part study, consisting of Part 1 (IV versus IM cross-over dosing in 16 psychedelic-experienced healthy participants) and Part 2 (single IV or IM doses of SPL028 in 22 healthy participants with little-to-no psychedelic experience). IV and IM SPL028 demonstrated a favorable safety and tolerability profile.

No serious adverse events were observed, and the majority of adverse events were mild to moderate and self-limiting. Furthermore, the study identified an IM dose of SPL028 that resulted in a breakthrough psychedelic experience, with a total duration ranging from 55 to 120 minutes. Phase 1 Data Summary: CYB004 and SPL028: IV and IM routes both safe and well-tolerated; CYB004 and SPL028 demonstrated similar PK and PD profiles which allows bridging of data across molecules; PK profiles for both molecules demonstrated concentrations in the effective range; IM dosing of SPL028 produced robust psychedelic effects lasting a short duration in the majority of subjects.