Cybin (NEO: CYBN) (OTCQB: CLXPF), a biotechnology company focused on progressing psychedelic therapeutics, has plans to advance the preclinical work for two of its deuterated tryptamine development candidates: its orally dissolving tablet (“ODT”) formulation of CYB003 and its inhaled formulation of CYB004. In the announcement, the company noted that the planned studies are part of the required U.S. Food and Drug Administration (“FDA”) enabling trials for investigational new drug applications (“INDs”). The results of the studies will be included in the submissions to the FDA and other regulatory bodies, including Health Canada and European Medical Association (“EMA”). The proprietary Cybin molecules are designed to have a faster onset and a shorter duration of action while still delivering the clinical benefits of psilocybin and other psychedelic compounds in development. They are being developed using an FDA-approved inhalation platform and proprietary ODT technology; if successful, the company intends to use the psychedelic molecules to improve therapeutic outcomes for psychiatric conditions. If successful, the candidates would advance into Phase 1 human clinical trials for specified psychiatric conditions. “Starting the IND-enabling trials for CYB003 and CYB004 is an exciting and important step forward for Cybin as we progress the study of these molecules,” said Cybin CEO Doug Drysdale in the press release. “Our scientific team is eager to produce a robust submission to the FDA that will advance our path forward to clinical trials. Once the studies have been completed, we plan to file IND applications, targeting treatment-resistant psychiatric disorders and certain forms of addiction, in 2021.”
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About Cybin Inc.
Cybin is a leading biotechnology company focused on progressing 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.
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