Cybin Receives FDA Approval for CYB003 Phase 3 in Treating MDD

Cybin Inc., a biopharmaceutical firm focused on developing psychedelic-based treatments for mental health, has achieved a significant milestone in its Phase 2 clinical trials for CYB003, a deuterated psilocybin analog intended to treat Major Depressive Disorder (MDD). Following a successful meeting with the U.S. Food and Drug Administration (FDA), the company is poised to initiate a Phase 3 program, marking the first global study of its kind for adjunctive psilocybin analog treatment of MDD.

The Phase 3 program, set to begin mid-year 2024, will involve multiple clinical sites across the U.S. and Europe, with an initial target of 15 U.S. locations and plans to add approximately 8 more in Europe. These sites are experienced in conducting psychedelic clinical trials and are licensed by the Drug Enforcement Administration (DEA) under Schedule I.

Cybin has engaged Worldwide Clinical Trials, a renowned contract research organization, to manage the trials. The company has demonstrated robust improvement in depression symptoms with CYB003, showing that 75% of patients were in remission after two doses. The treatment's safety profile is also promising, with no serious adverse events related to the drug and all events being mild or moderate.

The FDA has granted Breakthrough Therapy Designation (BTD) to CYB003, which facilitates an expedited review process and increased collaboration with the FDA. This designation is reserved for therapies that offer significant advantages over existing treatments for serious conditions. If approved, CYB003 could become the first psychedelic-based therapeutic for MDD.

The Phase 3 program will include two controlled studies and a long-term extension. The first study will assess a fixed repeat dose of 16mg CYB003 compared to placebo, aiming to replicate the Phase 2 results. The second study will compare two doses of CYB003 (16mg or 8mg) to placebo. The primary endpoint for both studies is the change in MADRS total score from baseline at Week 6, with a secondary endpoint at Week 12.

Cybin's mission is to innovate mental healthcare by providing new treatment options for mental health conditions. The company's pipeline includes CYB003 for MDD and CYB004 for generalized anxiety disorder, along with other investigational psychedelic compounds. With a network of partners and scientists, Cybin is advancing its drug discovery platforms, drug delivery systems, and treatment regimens.

Cybin is headquartered in Canada and operates in several countries, including the U.S., the UK, and Ireland. The company's commitment to rigorous scientific research and clinical trials is evident in its pursuit of FDA approval for CYB003, which could offer a new treatment option for those suffering from MDD.