By Lisa Wohl
The writer is a US-based health reporter
WELLINGTON, Florida, USA (IDN) — According to the World Health Organization (WHO) in Geneva, one in four people in the world will be affected by neurological or mental disorders at some point in their lives. Depression is a common mental disorder. Globally, more than 264 million people of all ages suffer from depression.
The COVID-19 pandemic has exacerbated mental health issues and heightened anxiety and triggered new conditions for people already suffering from mental illnesses and substance abuse. Thus, it is timely and empirical to explore new approaches and possibilities to treat these conditions.
Canadian biotechnology startup Cybin Inc. is a company that is advancing psychedelic therapeutics and is currently studying several compound molecules to treat anxiety and various forms of depression, including Major Depressive Disorder, Alcohol Use Disorder, and Anxiety. Across the pond, British company Compass Pathways, backed by PayPal co-founder Peter Thiel, is doing similar work.
Based on estimates derived from currently available U.S. Food and Drug Administration (FDA)-approved treatments, the current U.S. market is estimated at US$165M, with global forecasts at US$1.15B as of 2021. The market comprises multiple approved drugs still under patent protection, generics, and off-label use drugs.
GAD is marked by excessive anxiety and worry (apprehensive expectation) about a range of everyday topics/events. GAD is one of the most common mental disorders in both community and clinical settings. It is associated with increased use of health care services.
GAD is a prevalent condition, estimated to affect between 3% and 6% of the United States adult population.
Current global estimates are approximately US$2.99B and are projected to grow to US$4.5B by 2027. The market is currently made up of multiple approved drugs still under patent protection, generics, and off-label use drugs, including benzodiazepines, which risk addiction, misuse, and dependence.
According to WHO, one in 13 adults globally suffers from anxiety. Current FDA-approved medications for anxiety disorders include Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin, and Norepinephrine Reuptake Inhibitors (SNRIs).
These are a class of drugs that are effective in some people in treating depression. SNRIs are also sometimes used to treat other conditions, such as anxiety disorders and long-term (chronic) pain, especially nerve pain. SNRIs may be helpful if you have chronic pain in addition to depression.
However, SNRIs have a slow onset of action and side effects, including weight gain, nausea, vomiting, and sexual dysfunction, which may cause further depression. Many patients do not respond to SSRI or SNRI treatments for anxiety disorders.
Various studies reviewing the improvements in anxiety with psychedelic treatments showed a significant response to therapy and were relatively well-tolerated. In these studies, patients benefited from a faster onset of action with less addictive and detrimental effects.
“The decision to pursue anxiety disorders indications for CYB004 follows months of thoughtful, in-depth work by the Cybin development team. Careful consideration of many factors drives these decisions, including the prevalence of anxiety disorders, the measurable clinical endpoints, a realistic pre-clinical and clinical plan, along with an understanding of the effects of the molecule itself. For the Cybin team, this decision represents a further opportunity to help millions of sufferers of these all-too-prevalent disorders,” stated Doug Drysdale, Chief Executive Officer.
According to the WHO, depression is a leading cause of disability worldwide and is a major contributor to the overall global disease burden. While psychedelic medications are still a long way from being commercially viable, considering there have not been any significant improvements in SSRIs in almost three decades, some people who suffer from depression and anxiety disorders are willing to wait.
Others may turn to illicit “street” drugs to self-medicate and dull their mental anguish.
The theme of the United Nation’s 2021 International Day Against Drug Abuse and Illicit Trafficking on June 26 aims at combating misinformation. It promotes sharing the facts on drugs — from health risks and solutions to tackle the world drug problem to evidence-based prevention, treatment, and care.
According to Healthline, a new study shows that an estimated 32 million people in the U.S. have used lysergic acid diethylamide (LSD or Acid), psilocybin (“magic mushrooms”), or mescaline (peyote and other cacti) at some point in their lives.
Many have used one or more of these substances in the recent past. In some U.S. states, peyote is legal in Native American ceremonies, while psilocybin is legal in Oregon.
Psilocybin and psilocin are listed as Schedule I drugs under the United Nations 1971 Convention on Psychotropic Substances. Schedule I drugs are defined as drugs with a high potential for abuse or drugs with no recognized medical uses.
However, psilocybin mushrooms have had numerous medicinal, religious, and cultural uses in dozens of cultures throughout history and significantly lower potential for abuse than other Schedule I drugs.
Researchers Teri S. Krebs and Pål-Ørjan Johansen of the Norwegian University of Science and Technology used data from a randomly selected sample of more than 57,000 individuals ages 12 and older who were questioned for the 2010 National Survey on Drug Use and Health.
According to Krebs and Johansen’s study, the rate of lifetime psychedelic use was highest among people ages 30 to 34, with higher rates in men than in women. The authors also found that older adults were more likely to have used LSD and mescaline, whereas younger adults were more likely to have used psilocybin.
Cybin wants to study the effects of psychedelics on the brain. The company plans to leverage a budding partnership with Kernel to utilize the latter company’s Flow device to quantify brain activity during psychedelic experiences in real-time.
Kernel Flow is a non-invasive brain interface that records real-time cortical hemodynamics to establish precise patterns of brain activity. Hemodynamic response (HR) allows the rapid delivery of blood to active neuronal tissues. The brain consumes significant amounts of energy but does not have a reservoir of stored energy substrates.
“The real benefit of Flow is its portability and miniaturization. Other decent neuroimaging technologies exist today. However, the patient access that can be made possible from Flow’s portability can enable us to collect data on a much more frequent and longitudinal basis, providing a larger, more significant, and more valuable data set,” says Drysdale with probity.
“The ability to collect quantitative data from our sponsored drug development programs with Kernel’s Flow is potentially game-changing in terms of our ability to measure where psychedelics work in the brain in real-time and how we ultimately design our future therapeutics,” Drysdale continues.
“Cybin’s visionary approach to understanding and treating mental illness through psychedelic pharmaceutical therapies opens a new frontier for addressing human health and wellness,” says Bryan Johnson, Founder and CEO of Kernel.
Kernel’s opportunity with Cybin could assist the transition from the subjective self-reporting by member states to the UN’s annual World Drug Report to longitudinal, quantitative measurements and insights, thereby offering the promise of data-driven, personalized treatment protocols that may significantly improve safety and efficacy.
Cybin has announced the completion of its 51st pre-clinical study as it continues to progress its proprietary psychedelic molecules into Investigational New Drug (“IND”)-enabling studies.
The Cybin Research and Development team has completed its 51st in-vitro, and in-vivo evaluation of its growing number of psychedelic compounds designed for potential therapeutic applications for several mental health objectives.
To date, more than 50 novel compounds have been evaluated through collaborations with experienced Contract Research Organizations (CRO) for pharmacokinetic properties, metabolic stability, receptor binding, and safety to identify preferred candidates for further development.
While the FDA has granted psilocybin a “breakthrough therapy” designation, the WHO has yet to comment on the resurgence or efficacy of psychedelic research. [IDN-InDepthNews — 25 June 2021]
Image credit: dasGerhirn.info.
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