TORONTO - Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN), a biopharmaceutical company focused on psychedelic-based therapies, has announced its plans to initiate a Phase 3 clinical program for CYB003, a deuterated psilocybin analog intended as an adjunctive treatment for Major Depressive Disorder (MDD). This announcement follows a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), where alignment was reached on the design of the upcoming multinational and multisite Phase 3 studies.
The Phase 3 program is slated to commence around mid-year 2024, with 15 U.S. clinical trial sites and approximately 8 additional sites in Europe. These sites have been chosen for their experience with psychedelic clinical trials and DEA Schedule I licensing, which is expected to expedite the initiation process.
The program will consist of two controlled studies and a long-term extension, aiming to replicate the positive treatment response observed in the company's Phase 2 study. The primary endpoint for both studies is the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6, with a secondary endpoint at Week 12, compared to placebo.
CYB003 has demonstrated robust and sustained improvement in depression symptoms, with 75% of patients achieving remission after two doses (16mg) at the four-month mark. The drug has been well tolerated, with no drug-related serious adverse events or discontinuations due to adverse events reported.
Cybin's CEO, Doug Drysdale, expressed satisfaction with the FDA's guidance and the strength of CYB003's clinical profile. The company anticipates that the Breakthrough Therapy Designation (BTD) for CYB003, granted earlier this week, will provide an expedited review pathway and potentially reduce drug development timelines.
The BTD is reserved for drug candidates that show substantial improvement over available therapies for serious conditions. It includes fast track program features, intensive FDA guidance, and discussions on clinical trials and manufacturing development strategies.
Cybin was established with the mission to revolutionize mental healthcare through the development of proprietary drug discovery platforms, innovative drug delivery systems, and novel treatment regimens. The company is also developing CYB004 for generalized anxiety disorder and has a pipeline of investigational psychedelic-based compounds.
This news is based on a press release statement and constitutes a designated news release for the purposes of Cybin's prospectus supplements dated August 23, 2023, to its short form base shelf prospectus dated August 17, 2023, as amended December 22, 2023.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.