In this edition of "Rising High," The Fly conducted an exclusive interview with Doug Drysdale, Chief Executive Officer of Cybin (CYBN), a biopharmaceutical company focused on progressing psychedelics to therapeutics. Here are some highlights:
PSYCHEDELIC THERAPEUTICS: Cybin is a Canadian-based ethical biopharmaceutical company working with a network of partners and scientists to create safe, effective therapeutics for patients to address a multitude of health issues. The company, founded in 2019, is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
“Cybin is taking an interdisciplinary approach to bring psychedelic therapeutics to patients,” Drysdale said. “From novel drug development to optimized treatment protocols to supportive psychotherapy sessions, the patient experience remains paramount from bench to bedside.”
He noted the company has a highly experienced pharmaceutical team which has generated extensive intellectual property around Cybin’s platform technology, including significant opportunities for future programs.
“Our goal is to create novel psychedelic molecules designed to deliver a fast onset of action, a short treatment duration, and reduced side effects so that these therapeutics can be adopted by physicians, payers, and patients,” Drysdale said. “It is our belief that these treatments can potentially improve patient outcomes and reduce treatment times and costs compared to classic psychedelics.”
DECADES OF KNOWLEDGE: As competition continues to ramp up in the psychedelics space, Drysdale pointed to the work of Cybin’s research and development team to leverage decades of scientific and clinical psychedelics knowledge as a key differentiator.
“Leveraging the strength of our team and pre- and clinical research supports our goal to optimize the therapeutic benefits of classic psychedelics through the development of proprietary molecules that are designed to achieve less variability in plasma levels, faster onset of action, and shorter duration of treatment,” he said. “Classic psilocybin is a compound metabolized in the body to form psilocin; the agent known to induce a psychedelic effect.”
Drysdale added the variability of metabolism results in challenges with classic psilocybin, including a 60-90 minute onset for classic psilocybin to reach peak effects, a typical experience lasting for six to eight hours and a significant inter-patient variability of plasma levels of psilocin.
“Cybin’s deuterated psilocybin analog, CYB003, has been shown in preclinical studies to have an onset of action twice as fast as classic psilocybin, a duration of effect that is half as long as classic psilocybin, and much-reduced variability which may result in more predictable outcomes,” he said. “We also expect that CYB003 could be effective at lower doses than classic psilocybin as it appears to enter the brain more efficiently after dosing, which might result in fewer side effects. Cybin’s thoughtful approach to improving upon these classic compounds is expected to result in an improved patient experience with reduced clinic time and costs.”
MENTAL HEALTH INDICATIONS: Cybin has decided to focus development efforts on indications including depression, alcohol use disorder and anxiety disorders as these conditions affect hundreds of millions of people daily, Drysdale said.
“The total direct and indirect costs of treating mental health disorders are estimated to be around $2.5T globally each year,” he said. “According to the World Health Organization, depression affects approximately 280M people worldwide. Anxiety disorders impact up to 12% of the population, making them the most prevalent form of mental illness. Alcohol use is the third most significant and preventable cause of death, taking approximately three million lives each year. The need for these treatments comes during an era when we see numbers rising and a struggle for people to be successfully treated.”
Drysdale cited several academic studies showing psychedelic therapeutics appear to offer the potential to address the underlying conditions, perhaps removing and relieving symptoms for months after just a couple of dosing sessions.
“This path is a paradigm shift away from how we treat disorders like depression today,” he said. “With existing treatments, a daily dose is necessary to provide relief from symptoms for many patients, and some patients stay on the same treatment for decades. In about a third of people suffering from depression, even daily treatment with SSRIs does not alleviate their symptoms, and they need an alternative. Addressing these needs for patients is what drives us at Cybin to work toward revolutionizing mental healthcare.”
CYB003 IN MDD: “CYB003 is a psilocybin analog that overcomes particular challenges resident with naturally occurring psilocybin and is being developed as a novel chemical entity,” Drysdale said. “CYB003 is not expected to be materially different from psilocybin in terms of efficacy.”
Cybin does expect however that CYB003 will be superior regarding safety, predictability of effect, and variability between patients.
“It is also anticipated that the duration of the psychedelic effects of dosing with CYB003 will take half the time compared to traditional psilocybin,” Drysdale said. “A shorter term with a more predictable effect would significantly benefit clinics and our clinical practitioners’ resources and help alleviate the burden on the healthcare system and, subsequently, the financial burden on patients.”
The company expects to have an interim safety and PK readout from the Phase 1/2a clinical trial evaluating CYB003 in the coming months.
CYBOO4 IN ANXIETY: In July, Cybin completed the acquisition of a Phase 1 N,N-dimethyltryptamine study from Entheon Biomedical. Cybin will use the CYB004-E Study to gather important data to accelerate the CYB004 program into Phase 1 development by gathering essential safety and dosing optimization data that will inform the clinical path forward. Cybin designed the study to help better understand the dosing dynamics and optimization of DMT, which it expects to help progress its deuterated DMT program, CYB004. Cybin expects to have the results of its ongoing DMT study by 1Q23.
“The CYB004-E Study is an adaptive, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics of a target-controlled intravenous infusion of N,N-Dimethyltryptamine in healthy volunteers,” said Drysdale.
EXPANSION PLANS: Cybin, which was founded in Canada and conducts the majority of corporate functions from the region, also has operations in the U.S., the Netherlands, and Ireland.
“As a fully remote company, we have had the good fortune of finding leading talent without being constrained to specific geographies, while also establishing a presence in regions where our drug development efforts will be best supported,” Drysdale said. “While we don’t have any immediate plans for expansion, as a growing company in a widely expansive industry, we are always evaluating opportunities that can support our growth strategically.”
DRUG SCHEDULING: The CEO noted there are a number of challenges when working with novel therapeutics.
“Firstly, psychedelics are Schedule I substances, which requires us to overcome regulatory barriers when researching these molecules,” said Drysdale. “A DEA (or equivalent) license is mandatory to study these compounds, which takes additional time to obtain and affects each part of the supply chain, from chemical synthesis and shipping to analytical testing and clinical administration.”
Drysdale said Cybin has built a network of more than 50 partners and vendors with the appropriate licenses and expertise to support its work.
“Over the past few years, there has been tremendous interest and excitement around the potential of psychedelics as therapies,” he said. “Much more research must be conducted to truly gain mainstream support. Cybin has already acquired a license from the DEA, and we are conducting multiple preclinical and clinical studies to compile more data for our psychedelic molecules. The data we acquire from these studies will be a critical next step in advancing these treatments through clinic development.”
CHALLENGES: When looking at the largest hurdles facing the psychedelics space, Drysdale pointed to stigma as one of the biggest challenges within the industry.
“The stigma of mental health disorders and the stigma around the historical use of psychedelics,” he said. “Through our established partnerships, like with Deepak Chopra and The Chopra Foundation, we are committing to helping society move past these stigmas and to making it easier for us all to talk about our mental health.”
Drysdale said Cybin’s clinical work is aimed at demonstrating both the safety and efficacy of psychedelics as therapeutics for mental health disorders.
“We believe that by demonstrating how psychedelic analogs can help people with mental health conditions, we can help change the historical stigma associated with these molecules,” he said.
OPPORTUNITIES: As the psychedelics industry develops and matures, Drysdale said it is exciting that psychedelic research has finally reached escape velocity.
“After decades of scientific study and millennia of ritualistic use, this research has the potential to bring about a paradigm shift in treating conditions such as depression, anxiety, and addiction,” he said. “Given all the momentum around these treatments, we do not doubt that psychedelics are on a path to approval as treatments for mental health conditions.”
CANNABIS/PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Acreage (ACRHF), Akerna (KERN), Aleafia (ALEAF), Atai Life Sciences (ATAI), Audacious (AUSAF), Aurora Cannabis (ACB), Awakn Life Sciences (AWKNF), Ayr Wellness (AYRWF), Body and Mind (BMMJ), Canopy Growth (CGC), Cannara Biotech (LOVFF), Chicago Atlantic (REFI), Clever Leaves (CLVR), Columbia Care (CCHWF), Compass Pathways (CMPS), CordovaCann (LVRLF), Cresco Labs (CRLBF), Cronos (CRON), Curaleaf (CURLF), CURE Pharmaceutical (CURR), CV Sciences (CVSI), Delic Holdings (DELCF), Delta 9 (DLTNF), Entourage Health (ETRGF), Fire & Flower (FFLWF), Flora Growth (FLGC), General Cannabis (CANN), Greenlane (GNLN), GrowGeneration (GRWG), The Green Organic Dutchman (TGODF), Green Thumb (GTBIF), Goodness Growth (GDNSF), Hemp (HEMP), HEXO (HEXO), High Tide (HITI), India Globalization Capital (IGC), Indiva (NDVAF), Innovative Industrial Properties (IIPR), InterCure (INCR), IM Cannabis (IMCC), Wellbeing Digital (KONEF), Khiron Life Sciences (KHRNF), Lowell Farms (LOWLF), Lotus Ventures (LTTSF), MediPharm Labs (MEDIF), MedMen (MMNFF), Neptune Wellness (NEPT), NewLake Capital (NLCP), Organigram (OGI), Planet 13 (PLNHF), Reunion Neuroscience (REUN), Revitalist (RVLWF), RIV Capital (CNPOF), Relmada (RLMD), RYAH Group (RYAHF), Safe Harbor (SHFS), SLANG Worldwide (SLGWF), Sproutly (SRUTF), Stem Holdings (STMH), Small Pharma (DMTTF), Skye Biosciences (SKYE), SNDL (SNDL), Sunniva (SNNVF), TerrAscend (TRSSF), Tetra Bio-Pharma (TBPMF), Tilray (TLRY), Trulieve (TCNNF), Tryp Therapeutics (TRYPF), The Valens Company (VLNS), Verano Holdings (VRNOF), Village Farms (VFF), Wesana Health (WSNAF), Zynerba (ZYNE) and 4Front Ventures (FFNTF).
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