Cybin (NEO: CYBN) (NYSE American: CYBN), a biotechnology company focused on progressing psychedelic therapeutics, has received approval from the U.S. Food and Drug Administration (“FDA”) to proceed with its phase 1/2a first-in-human clinical trial evaluating CYB003; the company has received a “may proceed” letter and investigational new drug application (“IND”) clearance from the FDA. The approval means that CYB003 will be the first novel psilocybin analog to enter clinical development, with patient recruitment beginning immediately and pharmacokinetic and safety data readout anticipated by fourth quarter 2022. According to the announcement, Cybin’s CYB003 is a proprietary deuterated psilocybin analog being developed for possible treatment of major depressive disorder (“MDD”). A randomized, double-blind, placebo-controlled study, Cybin’s upcoming phase 1/2a trial is designed to evaluate people with moderate to severe MDD. During the trial, study participants will receive two administrations (placebo/active and active/active) with a response/remission being assessed after the first dose at week 3 and after the second dose at week 6. “We are extremely pleased to advance CYB003 into clinical development so quickly,” said Cybin CEO Doug Drysdale in the press release. “Our team has worked diligently to achieve this major regulatory milestone, and we look forward to collaborating with Clinilabs, our drug development partner, to accelerate this program. This phase 1/2a trial represents the first time that a psilocybin analog will be evaluated for the treatment of MDD and is the key next step toward our ultimate goal of providing a new and effective treatment for people suffering with mental health conditions. . . . Multiple academic studies have shown that psychedelic-based treatments, like psilocybin, may have the potential to revolutionize mental healthcare, but few companies have addressed the well-known limitations and side effects of oral psilocybin. We believe CYB003 has the potential to offer people in need with a more tolerable and potentially more effective treatment option. We look forward to advancing this important compound through clinical development.”
To view the full press release, visit https://nnw.fm/38rxP
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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