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HomeNewsBusinessFuture Priorities and Objectives for Cybin’s Clinical Development Programs

Future Priorities and Objectives for Cybin’s Clinical Development Programs

A biopharmaceutical company focused on advancing psychedelics to therapeutics®, Cybin Inc. outlined its upcoming priorities and near-term milestones that support the development of its CYB003 and CYB004 clinical programmes aimed at treating various mental health conditions.

CYB003 for the Treatment of Major Depressive Disorder (“MDD”)

According to Doug Drysdale, chief executive officer of Cybin, “Cybin approaches 2023 with the opportunity to hit a number of value-driving milestones, including significant advancements across our development pipeline.” As we continue to concentrate on the development of our novel investigational therapeutics focused at addressing the huge unmet demand for people suffering from mental health issues, these priorities will give crucial information to assist enhance our business.

Cybin is presently testing CYB003, a deuterated psilocybin analogue, in MDD patients as part of a Phase 1/2a clinical investigation. The Company stated today that by the end of February 2023, it intends to present an interim readout from the Phase 1/2a trial. A preliminary understanding of the safety and pharmacokinetic (“PK”) profile of CYB003 in humans is anticipated to be provided by the interim readout, together with initial findings regarding the psychedelic effect and duration of CYB003’s psychedelic effect. These results will assist in supplying the required dose range data for the existing Phase 1/2a trial as well as upcoming clinical investigations testing CYB003.

The first deuterated psilocybin analogue to ever begin clinical development is CYB003.

The purpose of CYB003 is to possibly alleviate the drawbacks and restrictions of oral psilocybin. Preclinical results showed that CYB003 had a quicker onset of action, a shorter duration of impact, and reduced fluctuation in plasma levels. With less intra- and inter-individual variability and a more consistent and predictable dosing regimen, CYB003’s therapeutic profile as a differentiating treatment for MDD is anticipated to minimise the time and resource burden on the healthcare system.

CYB004 for the Treatment of Anxiety Disorders

A Phase 1 exploratory trial called the “CYB004-E trial” is currently being conducted by Cybin to assess IV N,N-dimethyltryptamine (“DMT”) in order to gather crucial safety and dosing optimization data for the upcoming clinical development of CYB004 (deuterated DMT) for the treatment of anxiety disorders. There have been no clinically significant safety or tolerability problems found thus far in the CYB004-E trial. In order to support the other scheduled cohorts, Cybin anticipates applying key findings from the initial trial, such as dose optimization and dosing dynamics. These discoveries are anticipated to hasten Cybin’s intentions to start administering CYB004 to patients. By the end of February 2023, the Company intends to offer an update on its CYB004 programme.

DMT is not orally accessible in its natural state since it is swiftly metabolised by the body. Preclinical research suggests that the new chemical compound CYB004 may be able to outperform DMT. These studies specifically shown that CYB004 had improved dose titration with less side effects than oral and IV DMT, faster onset with lower doses, lower inter-subject variability, and enhanced oral and pulmonary bioavailability. In February 2022, Cybin obtained a composition of matter patent for CYB004 in the United States.

News Summary:

  • Future Priorities and Objectives for Cybin’s Clinical Development Programs
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