The TDR Three Key Takeaways for Numinus and Cybin’s Phase 3 Study of CYB003:
- Numinus being selected by Cybin to conduct research trials validates its research trial business segment.
- The Cybin Phase 3 Study of CYB003 received FDA Breakthrough Therapy Designation in March 2024.
- Numinus’ collaboration with Cybin could offer significant benefits for individuals suffering from Major Depressive Disorder.
Numinus Wellness Inc.(TSX:NUMI, OTC:NUMIF), a mental health care company, is advancing both traditional and innovative behavioral health treatments. Recently, it was announced that Cedar Clinical Research (CCR) will serve as a clinical site for Cybin’s Phase 3 multinational clinical trial of CYB003, targeting the adjunctive treatment of Major Depressive Disorder (MDD). This inclusion in the trial emphasizes Numinus Clinical Trials’ commitment to enhancing patient care through rigorous research and development.
The Phase 2 trial of CYB003 showed that 75% of participants with moderate to severe MDD achieved remission from depression symptoms after two 16mg doses. Following these results, the U.S. Food and Drug Administration (FDA) granted CYB003 a breakthrough therapy designation. This not only highlights the potential of CYB003 to transform MDD treatment but also speeds up the development process for quicker patient access to potentially significant therapies.
Source: Cybin
The Phase 3 trial of CYB003, set to start in mid-2024, will be conducted across 15 U.S. sites, including CCR’s facility in Murray, Utah. Dr. Paul Thielking, Chief Science Officer of Numinus, will lead as the Principal Investigator. His extensive experience and deep understanding of psychiatric disorders and treatment strategies will guide this crucial research, focusing on the safety and efficacy of CYB003 to support its progression towards FDA approval.
Numinus Clinical Trials is playing a proactive role in researching psychedelic-assisted therapies, a growing trend in the mental health sector. With several drug candidates advancing to later stages of clinical trials, 2024 is shaping up to be a year of progress for Numinus and psychedelic based mental health therapies. These developments are eagerly anticipated by the mental health community, which is hopeful for more effective treatments.
The FDA’s breakthrough therapy designation for CYB003 underlines its potential to significantly improve the treatment landscape for depression. The Phase 2 trial demonstrated high efficacy and a robust safety profile, with no serious adverse events reported. This supports CYB003 as a potentially transformative treatment for MDD, with the added advantage of possibly fewer side effects compared to traditional therapies.
The selection of Cedar Clinical Research as a site for the Phase 3 trial of CYB003 is a significant advancement for Numinus Clinical Trials and the field of mental health treatment. Numinus’ collaboration with Cybin could offer significant benefits for individuals suffering from Major Depressive Disorder. Want to keep up to date with all of TDR’s research and news, subscribe to our daily Baked In newsletter.