TORONTO–(BUSINESS WIRE)–Cybin Inc. (NEO: CYBN) (US NYSE: CYBN) (Cybin or the Company), a biopharmaceutical company focused on advancing “psychedelics into therapeuticsMTtoday announced its partnership with Clinilabs Drug Development Corporation (“Clinilabs”), a global, full-service contract research organization with deep expertise in central nervous system drug development, to complete the Company’s Phase 1/2a clinical trial of CYB003, a proprietary analog of deuterated psilocybin. CYB003 will be the first psilocybin analog to be evaluated in Phase 1/2a development for the treatment of major depressive disorder (“MDD”).
“We are delighted to partner with the Clinilabs team as we move forward in this important program towards a first-in-man phase 1/2a trial. Clinilabs brings a unique combination of scientific and operational experience and deep clinical research expertise across a range of psychiatric, neurological and substance use disorders,” said Doug Drysdale, CEO of Cybin. “Clinilabs is perfectly suited to help us accelerate the regulatory pathway for this promising therapeutic candidate and ultimately effectively treat people with MDD. »
In multi-species preclinical studies, CYB003 demonstrated significant advantages over conventional psilocybin, including less variability in plasma levels, faster onset of action, shorter duration of effect, and potentially better tolerance to a better overall outcome for patients. Cybin recently announced the completion of its IND-habilitation live preclinical studies of CYB003. The data from these studies supports progress toward an Investigational New Drug (“IND”) filing with the United States Food and Drug Administration (“FDA”) for the Phase 1/2a clinical trial. Cybin intends to submit an IND to the FDA in the second quarter of 2022 and plans to initiate the Phase 1/2a trial in mid-2022.
“About one-third to one-half of people with MDD show an inadequate response to antidepressant treatment. Treatment options for these patients are currently limited to increasing the dose, switching or combining antidepressants, or augmentation therapy, often with unsatisfactory results,” said Dr. Gary Zammit, President and CEO of Clinilabs. “It is a privilege to work with Cybin, an innovator in the development of new psychedelic therapies, to conduct its first human clinical trial of CYB003. This trial is designed to evaluate the efficacy and safety of CYB003 in patients with MDD and is among the first to evaluate a standardized psychedelic treatment regimen in this patient population.
CYB003 is derived from psilocybin, which is part of a family of molecules called indolamines that include more common neurotransmitters, like serotonin. Psilocybin is dephosphorylated to form its metabolite, psilocin, which can cross the blood-brain barrier. Given its structural similarity to serotonin, psilocin can easily activate the serotonin 5-HT2A receptor. CYB003 is a deuterated psilocybin analog that has the potential to effectively treat major depressive disorder and alcohol use disorder.
About Clinilabs Drug Development Corporation
Clinilabs Drug Development Corporation is the only global, full-service contract research organization (CRO) focused exclusively on central nervous system (“CNS”) drug development. With deep CNS expertise, we engage in the development of medicines that treat a range of psychiatric, neurological and substance use disorders, as well as rare and ultra-rare CNS diseases. Clinilabs partners with pharmaceutical and biotechnology companies to provide a full range of first-in-man to Phase 3, high-quality, timely and cost-effective clinical drug development services with the common goal of accelerating on the market for new drugs for the CNS. We are process driven but structured to be agile, delivering a personalized service that meets the needs of clients and projects of all sizes. Clinilabs has conducted more than 675 CNS clinical trials over our 21-year history and played a pivotal role in approving 19 new therapies in 10 CNS indications to help transform the lives of patients in the whole world.
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, to create safe and effective therapies for patients to treat a multitude of mental health conditions. Based in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom and Ireland. The Company is focused on advancing psychedelics into therapeutics by designing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
Cautionary Notes and Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and all statements preceded by, followed by, or containing the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “expect”, “predict”, “plan”, “seek”, “should” or similar expressions or their negative forms, are forward-looking statements. this press release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and therapeutic regimens to potentially treat psychiatric disorders.
These forward-looking statements are based on reasonable assumptions and estimates made by the management of the Company at the time such statements were made. Actual future results may differ materially because forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from the results, performance or achievements future expressed or implied by such forward-looking statements. These factors include, among others: the implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in the securities markets; expectations regarding the size of the psychedelic market; the Company’s ability to successfully achieve its business objectives; growth plans; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions on the markets in which the Company operates; and the risk factors set forth in the Company’s MD&A for the period ended December 31, 2021 and the Company’s registration statement dated November 9, 2020, which are available under the Company’s profile at www.sedar .com and with the US Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this press release are based on what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such statements. forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this press release. The Company undertakes no obligation to update any forward-looking statements of beliefs, opinions, projections or other factors should they change, except as required by law.
Cybin makes no medical, treatment or health benefit claims regarding the products offered by Cybin. The United States Food and Drug Administration, Health Canada, or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives, or other psychedelic compounds. The effectiveness of these products has not been confirmed by approved research. There is no guarantee that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives, or other psychedelic compounds will diagnose, treat, cure, or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of the products offered. Any reference to the quality, consistency, efficacy and safety of potential products does not imply that Cybin has verified it in clinical trials or that Cybin will complete such trials. Failure by Cybin to obtain the necessary approvals or research to commercialize its business could have a material adverse effect on Cybin’s performance and operations.
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