Aaron Bartlone has spent the last ten years working in the pharmaceutical and healthcare industry in various regulatory, safety and management positions. Before joining Cybin Inc., Aaron was the Chief Quality, Patient Safety, HSE & Risk Officer at UCB, Inc leading a team of 1500+ colleagues in 54 countries. At UCB he also was president, leading US commercial operations through the restructuring into CNS and Immunology Business Units with annual revenue of $2.2B. Before that he worked in various director level research, regulatory and managerial roles at Eli Lilly.
How did you first become interested in psychedelics?
I have spent much of my career bringing therapeutics to the market for neuroscience and psychiatric disorders, which has been a stale market. For many years, there has not been a change in the way that we treat mental illness. I decided to join a company that was disrupting the norm and creating treatments that can really change the lives of millions of people. My expertise in the pharma industry gave me the confidence to help this emerging industry. Cybin felt like the perfect fit, and the work that we have been able to do in just 2 years has been incredible. At this point in my career, there is no better place for me to be.
What is the mission of Cybin?
Cybin is on a mission to develop psychedelics into therapeutics. By doing this, we are trying to revolutionize mental healthcare. Our mission is strong because everyone on our team has a connection to mental health. We know the importance of making our mission become a reality, it’s the driving force to our team.
What novel psychedelic formulation is Cybin working on and for what indications?
All of Cybin’s psychedelic compounds are novel formulations. CYB003 and CYB004 are deuterated molecules of classical psychedelics. The psychedelic molecule CYB003 is a novel psilocybin analog being developed for the treatment of Major Depressive Disorder and Alcohol Use Disorder. We’re entering into a Phase 1/2a study with CYB003 this summer, which is an exciting step towards getting this treatment approved by the FDA. Our next program, CYB004, is a deuterated DMT molecule that is being researched for the treatment of anxiety disorders, including generalized anxiety disorder (GAD) and social anxiety disorder (SAD). With over 140 preclinical studies completed and clinical trials expected to begin this summer, we are moving these molecules from the bench to bedside.
How does CYB003 differ from oral psilocybin?
CYB003 is a deuterated psilocybin analog. By using deuteration (a process that involves replacing a hydrogen atom with deuterium, a stable hydrogen isotope), this modification can allow for optimized dose and duration for CYB003 compared to oral psilocybin. We have promising preclinical studies comparing second-generation molecules to first-generation molecules. CYB003 has shown a shorter hallucinogenic experience while having the same efficacy while allowing patients to have a shorter duration of treatment. By making the molecules faster-acting, we are able to scale the treatment options available. We believe that CYB003 has the potential to effectively treat major depressive disorder (MDD) and alcohol use disorder (AUD) with potential for reduced side effects associated with other psychedelic-based therapies currently in development
What validation have you seen for CYB003 as a treatment for depression and alcohol-use disorder?
There are a number of published studies with incredible results in substance use disorders and depression. Just recently, a study found that patients with severe depression who were given psilocybin for three weeks experienced rapid, sustained improvement in their symptoms. People metabolize psilocybin at different speeds, making it difficult to find one dose that works for all patient groups. There is strong demand for molecules with similar therapeutic properties but more controlled pharmacokinetic profiles. Encouraging preclinical data demonstrated CYB003 plasma concentration profiles were less variable than psilocybin and had improved brain penetration ratios. The data suggests CYB003 could result in therapeutic effects with safer dosing options and more predictable patient outcomes.
What validation have you seen for CYB004 and anxiety disorders?
CYB004 has the potential to effectively treat anxiety disorders, including Generalized Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD) by activating the 5-HT2A receptor. With classical DMT, a treatment that lasts only 15 minutes would not be ideal in a clinical setting. In its natural form, DMT is rapidly metabolized in the body and is not orally bioavailable. Our preclinical studies have shown that CYB004 has the potential to overcome these issues and provide increased oral and pulmonary bioavailability, faster onset with lower doses, less inter-patient variability, and better dose titration for fewer side effects and longer acting desensitization of the serotonergic receptors. We plan to have a pilot study for CYB004 this year, allowing us to collect more data on this treatment.
What regulatory challenges offer the biggest barriers to improving access to psychedelics for medical treatments and therapies?
Bringing any new treatment to patients takes many steps through the FDA. In order for the industry to start to successfully bring these treatments to market, we need more data. As there continues to be research published, this will have a positive effect on the potential to get a treatment to market.
On the regulatory side, health authorities are beginning to take action that facilitates more psychedelic research. We are seeing a profound shift in the amount of funding into psychedelic space. Releasing credible clinical research in psychedelics will become more mainstream.
Where do you see psychedelic medicines in the future and how much of an impact do you think they will make on healthcare as a whole?
The World Health Organization states that mental health disorders affect more than 900M people globally. The COVID-19 pandemic has brought depression and substance use disorder prevalence to an all-time high. The impact of these treatments would not only help the millions of people in need, but also their loved ones around them. With this research we have seen a resurgence in the way that we treat mental illness. We no longer have to accept treatments that cover up the symptoms. We are researching to find treatments that will change the mental health landscape.
What excites you the most about the future of Cybin?
The future of Cybin is bright, we have a team that is motivated to get a treatment to market and change the way we treat anxiety, depression, and addiction. In just 18 months CYB003 has gone from the bench, into clinical trials. I’ve never seen a team of our size be able to work at the pace that we do. Our team has over 400 years of combined pharmaceutical experience, partners that we align ourselves with, and a mission that we strongly believe in. This is the formula for success in a company. Every day we are working on making our future a reality, one step at a time.