Are Psychedelics the New Antidepressants?

Anxiety disorders are the most common mental illness in the US, affecting approximately 40 million adults each year, and despite the abundance of antianxiety medications available, treatment resistance occurs in roughly 30% of patients. Anxiety disorders have a significant economic impact on the US healthcare system, costing between $42.3 billion and $46.6 billion annually, meaning it’s essential to find alternative treatment options. Luckily, new research reveals that psychedelics may be the answer. Clinical trial results show that psilocybin, a potent psychedelic, has antidepressant effects in patients with depression and is more effective than escitalopram. Of course, this is just one of many successful studies involving the use of psychedelics as a treatment for mental illness.

Cybin Inc is focused on advancing psychedelics into therapeutics by designing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

On April 13, Cybin announced positive CYB004 preclinical data from a pharmacokinetic study evaluating its proprietary deuterated dimethyltryptamine (DMT) molecule, CYB004, administered by inhalation. Specifically, inhaled CYB004 showed significant advantages over intravenous and inhaled DMT, including longer duration of action and improved bioavailability. The study also demonstrated that inhaled CYB004 had a similar onset of effect and dose profile to IV DMT. These data may support the potential of inhalation as a viable and well-controlled delivery system for therapeutic psychedelics. Cybin is currently developing CYB004 for the treatment of anxiety disorders. The company expects to file a regulatory filing for a pilot study in the second quarter of 2022 and to initiate the pilot study in the third quarter.

“In many studies, DMT has shown to be a promising and effective psychedelic for the treatment of mental health issues. However, known side effects like disorientation and anxiety and its mode of administration have historically hindered its use and availability. CYB004 via inhalation may solve for these challenges and finally support a clinical path forward for this important therapeutic. As part of Cybin’s overall mission to create safe and effective psychedelic-based therapeutics, inhaled CYB004 is being developed to potentially overcome the limitations of IV DMT and become an important treatment option for anxiety disorders for patients and physicians,” said Doug Drysdale, Cybin’s CEO.

On April 8, Cybin announced the publication of an international patent application covering inhalation delivery methods for multiple psychedelic molecules, further reinforcing Cybin’s intellectual property (IP) position. The PCT application will allow Cybin to seek IP protection for multiple inhaled forms of psychedelic molecules that are currently being researched and developed by the company as well as other psychedelic molecules that may be developed in the future.

“The publication of this PCT patent application demonstrates our continued commitment to discovering and developing new psychedelic-based treatment options, in addition to identifying and combining potentially improved and well-controlled delivery systems with these clinical candidates,” said Doug Drysdale. “In addition, our progress to secure IP for unique psychedelic delivery methods strongly aligns and supports our current CYB004 pipeline program of deuterated DMT via inhalation, which is aimed at overcoming some of the known challenges of oral and IV-administered DMT.”

Cybin announced on March 31 that its sponsored feasibility study using Kernel Flow technology had conducted its first study visit. The main objective of the study is to evaluate a participant’s experience wearing Kernel Flow while in an altered state of consciousness following the administration of ketamine. Participants will receive either a low dose of ketamine or placebo while wearing the Flow headset, which is equipped with hi-tech sensors to record brain activity and will report their experience using structured questionnaires and validated assessments during study visits and at follow-up. The four-week study will also evaluate brain activity before and after administering the study agents – low-dose ketamine or placebo.