- Report notes significant and swift advancements in company R&D pipeline and overall business
- Preliminary data indicates CYB003 may provide significant treatment benefits that address limitations of oral psilocybin
- CYBN programs and new psychedelic chemical entities have potential to transform treatment landscape for various psychiatric and neurological conditions
Q2 2021 has been a transformative quarter for Cybin (NEO: CYBN) (NYSE American: CYBN), a biopharmaceutical company focused on progressing psychedelics to therapeutics(TM). The company released its financial and operational report for the period recently, with notable company milestones and achievements highlighted (https://ibn.fm/ucAed).
“The first half of the year has been a transformative period for Cybin that included significant and swift advancements in our research and development pipeline and overall business,” said Cybin CEO Doug Drysdale. “Through CYB003, we believe that we have identified a potentially safer treatment option for patients with depression and addiction disorders that we expect to have strong intellectual property protection and a positive pharmacokinetic profile for patients, providers and payers. We plan to move through the ongoing, remaining preclinical studies quickly and submit an investigational new drug application and clinical trial application in the second quarter of 20221, in the U.S. and the U.K. respectively.”
Cybin’s novel deuterated psilocybin analog, CYB003, was the focus of a preclinical study designed to explore and study the substance for potential treatment of major depressive disorder and alcohol use disorder. The company recently reported preliminary data indicating that CYB003 may provide significant treatment benefits that successfully address the challenges and limitations of oral psilocybin; those benefits include improved safety through less patient variability, reduced clinic times through faster onset of action and shorter duration of effect, and lower dosing through improved brain penetration. The company noted that the study also shows the treatment may produce fewer side effects. All of this points to an overall improved patient experience.
In its report, Cybin noted that it plans to complete the ongoing CYB003 preclinical studies in the first quarter of 2022. By Q2 2022, the company anticipates submitting an investigational new drug application to the U.S. Food and Drug Administration and a clinical trial application with the U.K. Medicines and Healthcare Products Regulatory Agency.
Other notable company achievements during the quarter include the U.S. Drug Enforcement Agency’s approval of a Schedule I manufacturing license for Cybin’s research lab, which is located in Boston. This license will enable CYBN to expand its internal research and development capabilities. The company also received FDA approval for its IND application to proceed with a feasibility study using Kernel Flow quantitative neuroimaging technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics. In addition, Cybin launched a first-of-its-kind psychedelic facilitator training program, based on EMBARK, a groundbreaking psychotherapy model that integrates leading clinical approaches to promote supportive healing with psychedelic medicine (https://ibn.fm/zWTkO).
“We continue to evolve our value-driving, patient-centered approach to potential treatments for mental health and addiction through our commitment to advancing programs such as EMBARK, that aims to facilitate psilocybin-assisted psychotherapy for frontline workers impacted by the COVID-19 pandemic, as well as targeted research using the Kernel Flow neuroimaging technology that we expect will allow us to quantitively understand the psychedelic experience in the brain as it is happening. We believe these programs combined with our proprietary psychedelic new chemical entities have the potential to transform the treatment landscape for various psychiatric and neurological conditions.”
Cybin is focused on progressing psychedelic therapeutics, making it an ideal advocate and sponsor of the EMBARK approach. A leading biotechnology company, Cybin is working to progress psychedelic therapeutics by utilizing proprietary drug-discovery platforms, innovative drug-delivery systems, novel formulation approaches and treatment regimens for psychiatric disorders.
For more information, visit the company’s website at www.Cybin.com.
NOTE TO INVESTORS: The latest news and updates relating to CYBN are available in the company’s newsroom at https://ibn.fm/CYBN
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