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 released positive phase 2 topline safety and efficacy data for CYB003, its proprietary deuterated psilocybin analog, being developed for the treatment of major depressive disorder (“MDD”). According to the announcement, study participants experienced a rapid, robust and clinically significant reduction of depression symptoms after a single dose of CYB003, with a clear incremental benefit of a second dose. The study showed a primary efficacy endpoint achieved with an impressive mean -14 point difference in Montgomery-Asberg Depression Rating Scale (“MADRS”) score reduction from baseline between CYB003 (12 mg) vs. placebo (p=0.0005) at three weeks, with incremental MADRS score reductions seen with 79% of patients in remission from depression after only two doses of CYB003 (12 mg). The company noted a favorable safety and tolerability profile with no treatment-related serious adverse events at both 12 mg and 16 mg doses.
Looking forward, the company anticipates submitting topline data to the U.S. Food and Drug Administration (“FDA”), along with a request for an end-of-phase-2 meeting. The company expects to receive additional 12-week durability data from the study in Q1 2024 and is planning to begin recruiting for a CYB003 phase 3 study by the end of Q1 2024. “We are delighted to share that CYB003 achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in four out of five patients in remission from their depression at six weeks,” said Cybin CEO Doug Drysdale in the press release. “This is an impressive finding and follows on from the unprecedented interim results we announced earlier this month. Importantly, the strength of the data supports progression to a phase 3 study of CYB003 for the treatment of MDD. . . . Completing our phase 2 study and presenting this extraordinary topline safety and efficacy data represents a much-anticipated milestone for us — a goal that we have all been tirelessly working toward. Our objective remains to design and deliver improved treatments for those suffering with mental health disorders, and we believe that we are one step closer to achieving that goal.”
To view the full press release, visit https://ibn.fm/RiTeo
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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