Cybin (NEO: CYBN) (NYSE American: CYBN), a biotechnology company focused on progressing psychedelic therapeutics, received Institutional Review Board (“IRB”) approval to begin its planned phase 1/2a clinical trial. The trial, the first-in-human phase 1/2a trial evaluating CYBN’s proprietary deuterated psilocybin analog CYB003, is slated to begin in mid-2022.The study will evaluate CYB003 for the treatment of major depressive disorder (“MDD”). Cybin applied for IRB approval just last month. According to the announcement, Cybin wholly owned subsidiary Cybin IRL Limited has partnered with Clinilabs Drug Development Corporation to conduct the randomized, double-blind, placebo-controlled study. The study involves participants receiving two administrations of the substance, along with a response/remission assessment at week 3 and week 6. In addition, participants will be offered an optional open-label follow-up study lasting up to 12 weeks. Clinilabs is a global, full-service contract research organization that has built a reputation for expertise in central nervous system drug development. “IRB approval of our trial protocol is a significant regulatory milestone for CYB003 as it leads us one step closer to potentially providing this important treatment option to people in need,” said Cybin CEO Doug Drysdale in the press release. “The team has worked tirelessly to move this program into the clinic, and we look forward to initiating the study in mid-2022 and further supporting our mission to develop psychedelics into therapeutics.”
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About Cybin Inc.
Cybin is a leading ethical biotechnology company, working with a network of world-class partners and internationally recognized scientists and 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, the United Kingdom and Ireland. The company is focused on progressing psychedelics to therapeutics(TM) by engineering proprietary drug-discovery platforms, innovative drug-delivery systems, and novel formulation approaches and treatment regimens for mental-health disorders. For more information, visit the company’s website at www.Cybin.com.
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