Cybin (NYSE American: CYBN) (Cboe CA: CYBN), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation, psychedelic-based treatment options, is reporting on its end-of-phase-2 meeting with the U.S. Food and Drug Administration (“FDA”). The meeting was regarding CYB003, the company’s deuterated psilocybin analog for the adjunctive treatment of major depressive disorder (“MDD”), and Cybin’s phase 2 study in MDD, which ended successfully last year. The company is now planning the first-ever global adjunctive phase 3 deuterated psilocybin analog depression study. According to the announcement, the company has received minutes from its meeting with the FDA and reached alignment on the design of the phase 3 program, which is slated to begin enrollment mid-year 2024. The multinational, multisite phase 3 program will target 15 sites in the United States, all of which have a background in running psychedelic clinical trials and are DEA Schedule I licensed, with plans to add additional sites in Europe. The company announced that it is working with Worldwide Clinical Trials, a global, full-service contract research organization with invaluable expertise in managing clinical trials for mental-health conditions.
“We are very pleased with the results of our end-of-phase 2 meeting with the FDA and appreciate the agency’s thoroughness and guidance during the process,” said Cybin CEO Doug Drysdale in the press release. “Having aligned on key features of the pivotal program, we look forward to initiating a multisite, multinational phase 3 program around mid-year. The strength of CYB003’s clinical profile to date, which showed that at four months after dosing, across the two doses, 60% of patients receiving 12mg and 75% of patients receiving 16mg of CYB003 achieved remission from depression symptoms. With positive durability data demonstrating sustained effects up to at least four months, BTD, and alignment with the FDA on our Phase 3 plan, we are positioned to move quickly to progress the program and bring relief and treatment alternatives to people who are desperately waiting.”
To view the full press release, visit https://ibn.fm/IP0aL
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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