Doug Drysdale | CEO, Cybin Corp

What are some of the biggest challenges in mental healthcare right now and how could psychedelic therapies address these challenges?

Mental health has become increasingly put in the spotlight during the pandemic, as we are recognizing the impact of COVID-19 on society as a whole, and especially among frontline healthcare workers and patients. Social isolation, job loss, and other consequences of the pandemic have resulted in a greater mental health burden. The statistics highlight this issue: 1 in 3 COVID-19 survivors are projected to experience depression or anxiety within 6 months (Lancet). Our team knows that there has to be a better way to treat mental health disorders, and that’s why we see psychedelic therapy has a potential answer to addressing the mental health pandemic we are experiencing today. In our view, psychedelics have the potential to transform the way that mental health disorders are currently treated. We believe that optimizing psychedelic molecules for faster onset of action, shorter treatment duration, and reduced side effects could potentially improve patient outcomes and reduce treatment time and costs. This could decrease the burden on patients who rely on daily SSRI’s for treatment.  

We have seen the impact of the COVID-19 pandemic on frontline clinicians and are aware of the serious mental health challenges that they are facing right now. Cybin has partnered with the University of Washington in the first study of psilocybin treatment for frontline healthcare workers. For more than a year now, frontline clinicians and healthcare professionals have made immeasurable sacrifices to protect public health in their communities. We consider it an honor and our duty to help support their own healing processes, post-COVID-19.  

Why is Cybin focusing on treating addiction disorders? Are there any other indications that Cybin finds promising?

Addiction disorders are one of the areas of mental health where there is significant unmet medical need and a lack of currently available treatment options for patients. This highlights the need for effective therapies. In particular, Cybin is focusing on alcohol use disorder (AUD), a chronic relapsing disorder that currently has no viable treatment options. AUD is characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. Approximately 5.8% or 14.4 million adults in the United States ages 18 and older had AUD in 2018  (ourworlddata.org). In 2018, the WHO reported that alcohol contributed to more than 200 diseases and injury-related health conditions, ranging from liver diseases, road injuries, and violence, to cancers, cardiovascular diseases, suicides, tuberculosis, and HIV/AIDS (ourworlddata.org). The need for these treatments comes at a time when we see numbers rising and a struggle for people to be successfully treated.  

We believe that there may be future opportunities to study the effects of psychedelic therapeutics on Tobacco Use Disorders and Opioid addiction.

What unique advantages can sublingual dosing bring to Cybin’s psychedelic treatments and research?

Delivering a psychedelic molecule sublingually (under the tongue) provides the potential for faster treatment onset. Many psychedelic treatments take several hours or even days to complete. Cybin’s sublingual film is designed to bypass the liver and deliver psilocybin directly across the sublingual membrane with the goal of providing a rapid onset of action, and potentially shorter treatment duration, at a lower effective dose. These benefits may decrease the amount of time that patients spend in the clinic, therefore reducing treatment costs and the use of healthcare resources.  

Our planned Phase 2a trial of CYB001 will be the first-in-human trial to evaluate Cybin’s sublingual psilocybin film formulation vs. an oral capsule.  

What is it about Cybin’s novel formulations that gives you a unique advantage? What have you done to modify or improve these formulations over the original molecules they are derived from?

Cybin’s psychedelic molecules are paired with drug delivery systems that are designed to optimize their therapeutic potential. We are currently advancing CYB001, which is our sublingual psilocybin formulation. We have received IRB approval to begin a Phase 2a study, which will be the first of its kind to assess sublingual formulation vs an oral capsule in patients. This is an important trial that brings us one step closer to advancing CYB001 in the clinic.

We are also advancing two novel deuterated tryptamines, CYB003 and CYB004, for the treatment of alcohol use disorder (AUD) and anxiety disorders, respectively. Cybin is selectively substituting hydrogen atoms on these tryptamine molecules with deuterium, or heavy hydrogen, with the goal of optimizing the duration of action of these novel tryptamines to make them more scalable, accessible and potentially improve treatment costs. We’re combining CYB003 with Catalent’s proprietary Zydis Orally Dissolving Tablet (ODT) technology, and CYB004 with an inhalation platform with the potential to deliver fast onset of action.

Cybin recently announced plans to advance preclinical work on two novel tryptamine-based formulations (CYB003 and CYB004). Can you discuss the next steps for these in terms of clinical trials and what their indications might be?

Once the preclinical work has been completed, Cybin expects to enter Phase I studies for these molecules. Cybin is currently on track to enter Phase 1 studies for CYB003 in 1Q22 and for CYB004 in 2Q22.

What kind of team are you building at Cybin?

Our team inspires me every day. The team shares a common passion for solving the challenges of mental illness as all of us have been impacted in some way by depression, anxiety, and addiction. It's a powerful mission that truly brings the Cybin team together.

What made you excited to partner with Kernel and how could their technology be innovative for psychedelic medicines?

The real advantage of the Kernel Flow technology is that it improves accessibility. By miniaturizing the technology into a wearable helmet, Kernel Flow will enable us to gain access to far more real-time brain activity data than was possible in the past.

Typically, fMRI can be expensive and difficult for patients to access, limiting the amount of data that can be gathered. However, we believe that the Kernel team has done an excellent job of taking neuroimaging technology and building it into a wearable device, which could make data collection more convenient. This may help us in the design of more targeted or effective treatments in the future.

What kind of value has Kernel’s neuroimaging technology brought to Cybin, especially your clinical research?

We’re excited to be sponsoring a first-of-its-kind feasibility study of Kernel Flow to assess ketamine’s effect on blood flow in the cerebral cortex. These studies will allow our team to collect more data than ever before on psychedelic therapy treatments. In the future, we believe that Kernel Flow could be more broadly used for studying brain activity during psychedelic experiences, and could help answer many questions about psychedelics, including the duration of their effects, and whether brain hemodynamics (blood flow) can be correlated with neural plasticity and be used to observe changes before, during, and after psychedelic treatment.

What do you believe is important for the public to know about the benefits of psychedelic therapies?

Psychedelic molecules are like a pharmaceutical intervention, providing the potential to remove a patient’s depressive symptoms or addictive cravings for months at a time, with just one or two doses. This could be absolutely life changing and transformative for patients.