Toronto – (business wire)–Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) (Cybin or company), a biotech company focused on advancing from psychedelics to therapeutics® today announced the targeted indication of its proprietary deuterated N,N-dimethyltryptamine (“DMT”) molecule, CYB004, for generalized anxiety disorder (“GAD”) with or without major depressive disorder (“MDD”). I announced that I chose it as a disease.
“Based on preclinical data, CYB004 has shown promise for the treatment of anxiety disorders. Nearly half of people who suffer from depression also suffer from GAD, making the need for more effective treatment options for GAD all the more urgent,” said Doug Drysdale, CEO of Cybin. says. “The prevalence of depression and anxiety has risen significantly since the pandemic and through its current development program Cybin has developed a revolutionary new drug to alleviate the emotional distress experienced by so many people around the world. We are optimistic that we may be able to provide a cure. We continue to see the potential of CYB004 as a new chemical to offer new avenues for mental healing. ”
Generalized anxiety disorder is characterized by excessive worry and tension that is not confined to specific environmental situations. Anxiety disorders are the most common mental health problem in the United States. In the United States, more than 40 million adults (her 19.1% of the total US population) suffer from anxiety disorders.1
Other Facts About Anxiety and Generalized Anxiety Disorder:
Among psychiatric disorders, GAD and MDD are the leading causes of disability worldwide. The presence of both GAD and MDD is strongly associated with poor prognosis, increased severity of symptoms, decreased quality of life, increased MDD recurrence, and higher suicide risk than either disorder alone.2-5
GAD affects 6.8 million adults each year, or 3.1% of the US population.6
Women are twice as likely to be affected by GAD.6
Worldwide, 14.7 million people have GAD in any given year.7
Twenty-three percent of adults prescribed SSRI discontinuation within 4 weeks and 36.5% within 3 months. Another report showed that about half of the patients discontinued antidepressants within his three months. 8
With a prevalence of approximately 9%, there is a lifetime risk of GAD.9
Based on the 2022 Generalized Anxiety Disorder Treatment Market Report, the economic burden of GAD is expected to grow to US$12 billion by 2030.Ten
Cybin is currently conducting a Phase 1 exploratory study (the “CYB004-E study”) evaluating IV N,N-dimethyltryptamine (“DMT”) to explore the future clinical potential of CYB004 for the treatment of GAD. Obtaining critical safety and dosing optimization data for development. To date, the CYB004-E trial has not shown any clinically significant safety or tolerability issues. Cybin hopes to translate key findings from the initial study cohort (such as dose optimization and dosing dynamics) to support the remaining cohorts planned for the trial. These findings are also expected to accelerate his Cybin plans to begin human administration of CYB004.
In its natural form, DMT is rapidly metabolized in the body and is not orally bioavailable. Based on preclinical studies, CYB004 has the potential to overcome the limitations of DMT. Specifically, these data demonstrate that CYB004 has increased oral and pulmonary bioavailability, more rapid onset at lower doses, less intersubject variability, and potential side effects compared to oral and IV DMT. was shown to be superior due to the relatively low dose titration.
Cybin received a US composition of matter patent covering CYB004 in February 2022.
The company plans to provide an update on the CYB004 program by the end of February 2023.
- GBD 2019 (2020). collaborator in illness and injury. 369 global burden of illness and injury in 204 countries and territories, 1990-2019: A systematic analysis of studies on the global burden of illness in 2019. Lancet, 396(10258):1204–22.
- Zhou Y, Cao Z, Yang M, et al. (2017). Generalized anxiety disorder comorbidity and its association with quality of life in patients with major depressive disorder. Sci Rep., 7(1):40511. Doi: 10.1038/srep40511.
- McIntyre RS, Woldeyohannes HO, Soczynska JK et al. (2016). Prevalence and clinical features associated with anxiety disorder designators as defined in the Diagnostic and Statistical Manual Version 5 in Adults with Major Depressive Disorder: Results of the International Mood Disorders Collaborative Project. Ther Adv Chronic Dis., 7(3):153–159. Doi: 10.1177/2040622315627805.
- Gaspersz R, Nawijn L, Lamers F, Penninx B (2018). Patients with anxiety depression: an overview of prevalence, pathophysiology, and impact on course and outcome. Curr Opin Psychiatry, 31(1):17–25.
- GlobalData, Center for Pharma Intelligence, Epidemiology and Market Size Database. Based on peer-reviewed literature, disease registries, and primary research.
- Kessler, RC, Petukhova, M., Sampson, NA, Zaslavsky, AM, & Wittchen, HU (2012). Twelve-month and lifetime prevalence and lifetime morbidity risk of anxiety and mood disorders in the United States. International Journal of Methods in Psychiatric Research, 21(3), 169-184.
- https://www.globenewswire.com/en/news-release/2022/10/27/2542715/0/en/Generalized-Anxiety-Disorder-Therapeutics-Market-Report-2022-to-2030-Abbvie-Inc- Pfizer-Inc-Eli-Lilly-and-Company-GSK-PLC-Abbott-Laboratories-Inc-and-Johnson-Johnson.html
Cautionary Statements and Forward-Looking Statements
Certain statements in this press release constitute forward-looking information. with respect to the historical facts contained in this press release, including without limitation statements regarding Cybin’s futures, strategies, plans, objectives, goals and targets, and statements that follow or contain the word “believe”; All statements other than statements, “expects”, “aims”, “intends”, “plans”, “continues”, “will”, “may”, “would”, “anticipates” , “estimate”, “estimate”, “forecast”, project”, “seek”, “should” or similar expressions or the negative thereof are forward-looking statements. Forward-looking statements in this news release include statements regarding the expected results and potential of the Company’s CYB004 program, the CYB004-E Phase 1 DMT clinical trial, and expected results. A planned timeline to provide updates on the CYB004 program and our plans to design proprietary drug development platforms, innovative drug delivery systems, new formulation approaches and treatment regimens for mental health conditions.
These forward-looking statements are based on our management’s reasonable assumptions and estimates at the time such statements are made. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual future results to differ materially. These factors may cause the company’s actual results, performance or achievements to differ materially from its stated future results, performance or achievements. It is implied by such forward-looking statements. Such factors include, among others: fluctuations in general macroeconomic conditions; fluctuations in the securities market; expectations regarding the size of the psychedelic market. A company’s ability to successfully achieve its business objectives. plans for growth; political, social and environmental uncertainties; relationships with employees; the existence of laws and regulations that may impose restrictions on the markets in which we operate; Discussions and analysis of the Company’s management for the three and six months ended September 30, 2022 and the risks described in the Company’s Annual Information Form for the year ended March 31, 2022 cause. Contact the US Securities and Exchange Commission (www.sec.gov) regarding sedar.com and EDGAR. Forward-looking statements contained in this news release are based on what our management believes, or believed at the time, to be reasonable assumptions, but actual results may differ from such forward-looking statements. We cannot assure our stockholders that our forward-looking statements will be consistent with them. There may be other factors that cause results that are not expected, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. We undertake no obligation to update any forward-looking statements regarding beliefs, opinions, projections or other factors if they change, except as required by law.
Cybin makes no claims of medical, therapeutic, or health benefits for products Cybin suggests. The U.S. Food and Drug Administration, Health Canada, or other similar regulatory agencies have not evaluated claims regarding psilocybin, psychedelic tryptamines, tryptamine derivatives, or other psychedelic compounds or dietary supplements. The efficacy of such products has not been confirmed by accepted research. , or preventable. Vigorous scientific research and clinical trials are required. Cybin has not conducted any clinical trials regarding the use of the proposed product. References to the quality, consistency, efficacy and safety of a potential product do not imply that Cybin has so validated in clinical trials or that Cybin has completed such trials. Cybin’s failure to obtain the necessary approvals or research to commercialize its business could have a material adverse effect on Cybin’s financial results and operations.
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