Cybin (NYSE American: CYBN) (NEO: CYBN), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics(TM),” today announced the submission of an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”). According to the update, the IND is for Cybin’s phase 1/2a first-in-human clinical trial evaluating CYB003, a proprietary deuterated psilocybin analog, for the treatment of major depressive disorder (“MDD”). “Following the successful completion of our IND-enabling work just last month, we are very excited to have reached this major milestone toward advancing CYB003 into clinical development so quickly. Based on preclinical studies, our proprietary psilocybin analog has the potential to offer numerous advantages over classic psilocybin with the potential to ultimately provide better outcomes for people suffering with MDD,” said Cybin CEO Doug Drysdale. “This FDA submission is the next major step in the advancement of CYB003, and we continue to work tirelessly to bring this innovative therapeutic option to people as quickly as possible. We look forward to continuing to work with the FDA to initiate the phase 1/2a trial in mid-2022.”
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About Cybin Inc.
Cybin is a leading ethical biopharmaceutical company working with a network of world-class partners and internationally recognized scientists on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, United Kingdom and Ireland. The company is focused on progressing Psychedelics to Therapeutics(TM) by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health 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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