A Milestone Week for Cybin as Company Approaches Phase 3 for Psychedelic Depression Treatment
Intense investor interest saw 13 million Cybin Inc (Nasdaq: CYBN) shares change hands in intraday trading on Thursday, up from its average of around four million shares. The stock closed 2.14% higher after the company announced it had completed a positive End-of-Phase 2 meeting with the FDA for CYB003, its deuterated psilocybin analog for the adjunctive treatment of Major Depressive Disorder (MDD).
Cybin also announced this week that it had been granted Breakthough Therapy Designation for CYB003 by the FDA. If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD.
Commenting on this week’s news, Doug Drysdale, Chief Executive Officer of Cybin, said, “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. Having aligned on key features of the pivotal program, we look forward to initiating a multisite, multinational Phase 3 program around mid-year. 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.”
Cybin stated that enrollment for its multinational, multisite Phase 3 program will commence in mid-2024. The company is targeting 15 sites in the US, and intends to add approximately eight additional sites in Europe.
Highlights
Cybin’s program will be the first ever adjunctive Phase 3 deuterated psilocybin analog depression study globally, and follows the successful completion of the Company’s Phase 2 study in MDD completed at the end of 2023.
The company’s Phase 2 trial of CYB003 in MDD demonstrated robust and sustained improvement in depression symptoms at four months with 75% of participants receiving two 16mg doses achieving remission and no longer showing signs of depression.
Cybin has engaged Worldwide Clinical Trials, a global, full-service contract research organization with deep expertise managing clinical trials for mental health conditions, including major depressive disorder.
About Cybin
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 and 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 company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.
