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Cybin Inc
Symbol CYBN
Shares Issued 405,910,711
Close 2024-01-05 C$ 0.54
Market Cap C$ 219,191,784
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Cybin says CYB004, SPL028 well tolerated in phase 1

2024-01-08 11:46 ET - News Release

Mr. Doug Drysdale reports

CYBIN ANNOUNCES POSITIVE TOPLINE DATA FROM PHASE 1 STUDIES OF PROPRIETARY DEUTERATED DMT MOLECULES CYB004 AND SPL028

Cybin Inc. has released positive safety, pharmacokinetic and pharmacodynamic data from its phase 1 studies of CYB004 (intravenous) and SPL028 (IV and intramuscular) 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 pharmacokinetics and pharmacodynamics 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.

"The positive data from our phase 1 studies of CYB004 and SPL028 are highly encouraging with the combined data from these studies enabling us to prioritize our 2024 development plan for our deuterated DMT program. Importantly, these are the first-in-human studies of deuterated DMT in healthy participants. We are pleased that both the IV and IM administrations produced robust psychedelic effects and were safe and well tolerated. We are especially encouraged that the IM route produced psychedelic effects in the majority of subjects, with a short-duration psychedelic experience from a single administration of SPL028," said Doug Drysdale, chief executive officer of Cybin. "These results for IM dosing of deuterated DMT are highly promising and will help inform dosing in future clinical trials, saving time and resources by eliminating the need for further formulation studies of other methods such as subcutaneous dosing."

Dr. Amir Inamdar, chief medical officer of Cybin, added: "The completion of our phase 1 CYB004 and SPL028 studies represents a significant milestone in the clinical advancement of our deuterated DMT program. From these studies, we identified a dose that resulted in strong psychedelic effects, was well tolerated and we believe will result in therapeutic efficacy. Collectively, these positive results will inform a more targeted approach and support an accelerated path to a phase 2 deuterated DMT study in GAD in early 2024."

Phase 1 CYB004 top-line 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 and infusion) in 12 participants, and Part C (IV CYB004 bolus plus or minus 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 Q1 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 five minutes and persisted for about 40 minutes after the bolus without the need for an extended infusion; and

  • 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 top-line results

The company today 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 crossover 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 favourable 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 allow bridging of data across molecules;

  • PK profiles for both molecules demonstrated concentrations in the effective range; and

  • IM dosing of SPL028 produced robust psychedelic effects lasting a short duration in the majority of subjects.

"With these important deuterated DMT datasets in hand, as well as the recently announced positive findings from our phase 2 study of CYB003, our deuterated psilocybin analogue in development for the treatment of major depressive disorder, we are well positioned to advance both programs as we pursue our goal of creating safe and effective treatments for multiple mental health disorders," concluded Mr. Drysdale.

About Cybin Inc.

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 health care 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 analogue 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.

Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland.

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