Cybin (NYSE American: CYBN) (Cboe CA: CYBN), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, met with the U.S. Food and Drug Administration (“FDA”) to hold a Type B Initial Breakthrough Therapy Meeting. The meeting, which was held last week, was regarding the company’s plans to initiate its phase 3 pivotal trial of CYB003 for the adjunctive treatment of MDD. According to the announcement, CYBN anticipates starting the study, which will include 30 clinical sites across the United States and Europe, later this summer.
“Following our productive Type B meeting, we continue to expect to commence our phase 3 pivotal program in late summer,” said Cybin CEO Doug Drysdale in the press release. “Having selected 30 clinical sites across the United States and Europe, we are eager to initiate this next phase of clinical development and to build on the positive impact of CYB003 to date. In our phase 2 study, CYB003 showed a robust and sustained effect, with 75% of patients in remission from depression four months after two 16 mg doses. We expect to report 12-month efficacy data from the phase 2 study in the fourth quarter of this year. We look forward to ongoing engagement with the FDA as we advance our path to bringing new, improved treatment options to patients and providers.”
Cybin has also realigned its Governance and Nominating Committee as well as its Compensation Committee. The Governance and Nominating Committee will now consist of Eric Hoskins as chair along with Mark Lawson and Theresa Firestone; the Compensation Committee will include Grant Froese as chair along with Lawson and Firestone. All committee members are existing independent directors,
To view the full press release, visit https://ibn.fm/sdeoj
About Cybin Inc.
Cybin is a clinical-stage breakthrough neuropsychiatry company on a mission to create safe and effective next-generation 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 dDMT 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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