Amir Inamdar is the chief medical officer of Cybin Inc. He is a qualified psychiatrist and pharmaceutical physician with over 20 years of clinical and drug development experience and has successfully progressed numerous candidate drugs through preclinical development and early phase clinical trials to proof-of-concept studies. Amir is experienced in leading global teams and overseeing development of novel medications across a range of psychiatric indications including treatment resistant depression, narcolepsy, anxiety, schizophrenia, bipolar disorder and substance use disorders. Previously, he has led clinical drug discovery teams as a medical director for AstraZeneca, Takeda, and GlaxoSmithKline.
What first sparked your interest in psychedelics as a potential medical treatment?
I have been working in mental health for almost 20 years. In my clinical practice, I soon realized that while the amount of suffering was huge, the treatment options are extremely limited. This inspired me to move into research where I could work towards finding innovative treatments. One day, about 10 years ago, while going through documents in an old office cupboard, I discovered an abandoned copy of Aldoux Huxley’s two essays - ‘The doors of perception’ and ‘Heaven and Hell’. What I read blew my mind! Huxley’s description of mind-altering experiences with mescaline and the immediate and long lasting effects were truly eye opening! This inspired further inquiry into this area and what I learned from published and empirical data fundamentally changed the way I viewed treatment of mental health conditions.
I’ve worked with and progressed many novel compounds from the pre-clinical stage into the clinic but have not been as excited for a treatment as I have been with psychedelics. For decades, we have only been able to offer largely ineffective and temporary fixes to people suffering from mental problems. Psychedelics, however, are a game changer. Done right, these treatments will fundamentally change the way we approach the treatment of mental illnesses. We have an opportunity to really change the lives of people who struggle daily with mental illness.
How do you think psychedelics can address the unmet needs of those who suffer from mental illnesses?
Current treatments are symptomatic and only address some of the symptoms for most patients. For example, in people suffering from anxiety, benzodiazepines or antidepressants are usually prescribed. These drugs only offer temporary relief and often after treatment is stopped, symptoms return. Therefore, they must be taken long term – for years, if not lifelong. These are also associated with some nasty dose-limiting side effects such as sedation, gastrointestinal upset, sexual dysfunction, and weight gain.
Psychedelics have the potential to address these shortcomings. Treatment with psychedelics fundamentally addresses the maladaptive patterns of thinking that are behind many of these conditions, meaning that effects of treatment are much more durable so they may have to be taken infrequently — once every month or several months. Moreover, the side effects associated with daily intake of antidepressants or benzodiazepines are not usually an issue with psychedelics. This would be life changing for many patients.
What do you see as the greatest challenge in the drug development process for psychedelics?
Psychedelics are Schedule I substances. Due to this status, there are regulatory barriers to overcome when researching these molecules. Companies must acquire a DEA license to study the compounds, which often takes a long time. Ultimately, we need more research funded into these compounds to have more mainstream support in creating these therapeutics. Over the past few years there has been tremendous support, but there is still much to be done.
At Cybin, we have already acquired a license from the DEA, and are conducting multiple pre-clinical and clinical studies to create more data on our psychedelic molecules. We are now advancing into clinical trials for CYB003 and CYB004. The data that we acquire from these studies will be a critical next step in advancing these treatments to the clinic.
How are the novel molecules and delivery methods that Cybin is developing going to help provide more accurate clinical results and a better experience for the patient?
We are taking what exists in nature and developing novel molecules and methods of delivery to address challenges. For example, with classical DMT; it is metabolized rapidly in the body so taking it orally on its own is not feasible. With our CYB004 program, we are planning to deliver this via inhalation which addresses this issue of fast metabolism of DMT. Based on our pre-clinical experiments, deuterated DMT delivered via inhalation has shown great potential to overcome these limitations of classical DMT. Pre-clinical studies suggest that CYB004 provides increased oral and pulmonary bioavailability, faster onset of action, need for lower doses, potential for less patient variability, and better dose titration for fewer side effects. CYB004 has the potential to effectively treat anxiety disorders which remain an area of significant unmet need.
What clinical trials is Cybin currently advancing?
Cybin is currently advancing 4 clinical trials. Our Phase 1/2a study for CYB003, Kernel Flow’s feasibility study (Cybin sponsored study), The University of Washington’s psilocybin study, and CYB004’s pilot study are all scheduled to be conducted in 2022.
In March, Cybin announced the initiation of a feasibility study evaluating Kernel’s quantitative neuroimaging technology, Kernel Flow. The commencement of the Kernel feasibility study marks a truly exciting moment, not only for Cybin and Kernel, but also for the entire field of psychedelic drug development. Having data recorded in real-time during a psychedelic experience has not been possible until this time. The data collected will support Cybin’s leading research efforts as we move our important treatment options through regulatory discussions and late-stage clinical development.
CYB003 will be the first psilocybin analog to be evaluated in Phase 1/2a development for the treatment of major depressive disorder. After completing pre-clinical studies last month, we are planning to advance CYB003 into a Phase 1/2a study this summer with our partners at Clinilabs.
CYB004, Cybin’s deuterated DMT molecule completed pre-clinical studies last month. We are planning to initiate a pilot study for CYB004 this year, evaluating it as a potential treatment for general anxiety disorders.
Cybin recently announced the successful completion of in vivo preclinical studies for its psychedelic formulation, CYB003. Can you share more about this milestone and how it will help advance CYB003?
CYB003 is a psilocybin analogue that addresses key issues with naturally occurring psilocybin and is being developed as a novel chemical entity (NCE). Before conducting any clinical study with an NCE, the FDA and international regulations require completion of a standard set of studies in animals and in the lab to establish preliminary safety and efficacy before any testing in humans can commence. This is where the vast majority of development programs fail. CYB003 is not materially different from psilocybin in terms of efficacy, but it is expected to be superior in terms of safety, predictability of effect and variability between patients. Completion of pre-clinical studies is a critical step toward moving CYB003 into the clinic – an impressive journey that took less than 18 months since discovery of the CYB003 molecule. CYB003 is specifically engineered to address some of the issues seen with classical psilocybin. CYB003’s onset of action is faster, and the duration of effect is shorter, therefore improving convenience for clinical administration. The data from our in-vivo preclinical studies demonstrate that CYB003 is well-tolerated following several doses in multiple species and support the advancement toward an investigational new drug (IND) filing with the FDA for a Phase 1/2a first-in-human clinical trial in patients with MDD.
Based on its attractive pre-clinical results, we believe that CYB003 has the potential to be a novel and effective treatment for the many people suffering from MDD.
How will Cybin’s partnership with Kernel allow for safer, more data-oriented trials through neuroimaging?
Cybin’s partnership with Kernel is unique because it allows us to access innovative neuroimaging technology that can quantify brain activity in real time during a psychedelic experience. This is groundbreaking since it allows us to gather quantitative rather than subjective data, which could help paint a clearer picture of how psychedelics are working in the brain. As we get further along in clinical development, having this quantitative data will be key.
Our current sponsored study using Kernel Flow technology is looking at the psychedelic effects of ketamine on the brain. The results of that study should be available by the end of 2022, and we are looking forward to further studies accompanied by Flow Technology.
What is the most common misconception you think there is around psychedelics?
One of the most common misconceptions I hear about psychedelics are that they are addictive. There have been multiple studies that have shown that this is not the case. In order to end the many stigmas surrounding these compounds, we need to continue to research, educate, and further broadcast the work that so many are doing. In order to end the misconceptions, there is work to be done, but I believe we can continue to create a paradigm shift in the way that these compounds are viewed.
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