Cybin is driven by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches – developing differentiated next-generation psychedelic therapeutics – and treatment regimens to address the unmet needs of patients across a multitude of mental health issues.
After receiving just two doses of one of Cybin’s developing drugs – three weeks apart – a staggering 75% of patients were still in remission from depression four months later.
In this interview we dig deep on treatments, psychedelics, what is happening with the FDA, and the hope these treatments could offer those suffering depression, mental health disorders, addictions, and anxiety.
LL: It’s great to have this opportunity to speak to you, Doug, could you tell us a bit about yourself?
DD: I’ve been in drug development for over 30 years, building various drug development companies. In my early career, I started with R&D, licensing, and partnerships and then moved to M&A, acquiring numerous companies. The second half of my career has involved running four pharma companies. I founded a generic company in 2008, led a public specialty pharma company, and a NASDAQ-listed CDMO. I’ve been with Cybin for about four years now.
LL: Can you elaborate on how second-generation psychedelics like deuterated psychedelic N,N- dimethyltryptamine (DMT) and psilocybin are transforming the treatment landscape for mental health disorders such as depression and anxiety?
DD: We’ve taken DMT and applied second-generation modifications to it. DMT usually has a short, intense experience of about 5-10 minutes. We extended the experience to about 90 minutes to allow more therapeutic work to be done. We’re studying this in a phase two trial for generalized anxiety disorder. With psilocybin, which is a prodrug converted to its active form in the body, we’ve removed the metabolic step to reduce variability between individuals. The deuteration improves bioavailability and brain penetration, making it more efficient. We’re entering phase three for this in major depressive disorder, with the asset having breakthrough therapy designation from the FDA.
The significance here is that these treatments could be the biggest breakthrough in psychiatry in 40 years. Unlike SSRIs, which only treat symptoms, these psychedelics show rapid reduction in symptoms, with patients often seeing improvements within a day. In our phase two study, we administered two doses three weeks apart, and 75% of patients were in remission four months later. This suggests a potential to change the course of the disease rather than just alleviating symptoms.
LL: There were attempts to use psychedelics in the 60s, particularly on soldiers with PTSD, but they were stopped for various reasons. It’s great to see this coming full circle.
DD: Yes, political issues in the 60s led to the Nixon administration banning these treatments, creating a stigma and a war on drugs. Overcoming this requires robust safety and efficacy data. The FDA’s support now is crucial, and they’ve granted several Breakthrough Therapy designations to psychedelic molecules. Europe is a bit more conservative, but the UK is relatively advanced in regulatory terms. Reimbursement is more challenging in Europe, but we are focused on developing treatments for these markets too.
LL: Given the high rates of mental illness in the US, how do you see psychedelics playing a long-term role in addressing this widespread issue?
DD: One in five Americans experience some form of mental health disorder annually, and half of us will in our lifetimes. Depressed patients are a significant burden on the healthcare system. If we can remove patients from chronic drug treatment and free them from depression, it could alleviate a lot of strain on the system. We need more psychiatrists and psychologists, but with psychedelics, we might only need to administer a few doses every six or twelve months, freeing up capacity and reducing treatment costs.
LL: Given the high rates of mental health disorders among children and adolescents, can you see potential applications of psychedelic therapies for younger populations in the future?
DD: We hope so, but we need to be cautious. These treatments haven’t been tested in younger people yet. In our phase two study, participants are over 21. The FDA may want us to look at adolescents as a post-approval commitment. Psychedelics induce neuroplasticity, creating new networks and connections in the brain. While younger brains are already quite plastic, we need to understand how these treatments work for them.
LL: Can you share some insights from the latest data on CYB004 and its implications for treating generalized anxiety disorder?
DD: Cybin is developing CYB004 for the treatment of anxiety disorders, specifically generalized anxiety disorder and it is currently in phase two for generalized anxiety disorder, so we don’t have efficacy results yet. We’ve conducted five studies on dosing, safety, administration, and formulation. Efficacy data will be available later this year. Our data on CYB003, a psilocybin analog for depression, shows that after two doses, 75% of patients were in remission for at least four months. We hope to see benefits extending beyond that period.
LL: How do the safety profiles of deuterated psychedelics compare to traditional treatments?
DD: We don’t administer these treatments daily, so any side effects are limited to the dosing period. In our phase two study, we haven’t seen any serious adverse events. Most common side effects were nausea, headache, and transient increases in blood pressure, all of which resolved without intervention. The safety profile so far is very clean.
LL: What feedback have you received from patients who have participated in these studies?
DD: The feedback has been remarkable. Patients who have suffered from depression for over a decade show significant improvement, often within a day of treatment. They become strong advocates for the treatment because of the transformative experience. Therapists are also excited because they finally have a tool that can truly help their patients.
LL: What do you think are the main challenges of getting these treatments to doctors and patients?
DD: From a regulatory standpoint, we have clarity from the FDA. The challenge will be in marketing, distribution, and patient access. These treatments need to be given under supervision in a controlled setting. Thankfully, there are already centers in the US set up for similar treatments like TMS and esketamine, which we can utilize. Europe, however, will require more creativity due to the lack of such centers.
LL: Are you currently linking to the UK and other European countries, or are you focusing on the US first?
DD: Our phase three program involves about 70 sites, including several in Europe. We aim to execute and establish the phase three program before considering additional requirements for European approvals, such as comparisons to standard care.
LL: How have you tackled patient diversity in your trials?
DD: Most studies with psychedelics have predominantly involved white populations. In our phase three program, we aim to have a more representative sample. We are working across 70 sites, which should help us achieve this goal. We exclude individuals with a history of bipolar, psychosis, or schizophrenia.
LL: Are there potential applications beyond mental health for psychedelic therapies?
DD: Yes, these treatments have potential in PTSD, postpartum depression, eating disorders, and addictions like opioid, alcohol, and tobacco use disorders. Psychedelics can help break habits and negative thinking patterns, making them well-suited for treating addictions.
LL: What personally drives your passion for pioneering psychedelic-based therapies?
DD: Like many, I’ve had family members affected by depression and addiction. My aunt took her own life due to depression, and my mom died of lung cancer from smoking. Professionally, I’ve seen that scientific progress is usually incremental, but psychedelics offer a rare opportunity for a significant breakthrough in psychiatry. It’s a once-in-a-career chance to make a transformative impact.
