Cybin (NEO: CYBN) (NYSE American: CYBN), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment options, has completed dosing of the final cohort for its phase 2 CYB003 study. According to the announcement, the company anticipates reporting topline efficacy data later this year; Cybin is also looking forward to the potential for a phase 3 CYB003 study to begin early next year. The phase 2 study is designed to evaluate CYB003, a proprietary deuterated psilocybin analog program in development for the potential treatment of major depressive disorder (“MDD”). The company noted that the phase 2 study is examining the safety, tolerability, pharmacokinetics and pharmacodynamics, and psychedelic effect of ascending oral doses of CYB003.
The study comprises six cohorts, with the following doses being administered: 1mg, 3mg, 8mg, 10mg, 12mg and 16mg. Thus far CYB003 has been shown to be safe and tolerable at all six doses with no serious adverse events or discontinuations due to adverse events having been observed. “We are extremely pleased with the rapid progression we have made from initiation to completion of dosing across all cohorts in our phase 2 CYB003 MDD study,” said Cybin CEO Doug Drysdale in the press release. “With topline efficacy data expected later this year, we are focusing on the upcoming data submission to the U.S. Food and Drug Administration (‘FDA’) and readying ourselves to scale for a potential phase 3 pivotal study early in 2024. We believe this a value inflection point for Cybin, as we continue to pursue our goal of improving the treatment landscape across mental health disorders.”
To view the full press release, visit https://ibn.fm/CSNxj
About Cybin Inc.
Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental-health conditions. Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug-discovery platforms, innovative drug-delivery systems, and novel formulation approaches and treatment regimens. The company is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder, and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder; the company also has a research pipeline of investigational psychedelic-based compounds. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. 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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