CCR Chosen for Cybin's CYB003 Phase 3 Trial

3 June 2024
Numinus Wellness Inc., a company dedicated to enhancing mental health through innovative therapies, has announced that its research affiliate, Cedar Clinical Research (CCR), has been selected to participate in a significant Phase 3 clinical trial for CYB003, a drug developed by Cybin for the treatment of Major Depressive Disorder (MDD). The study aims to evaluate the safety and effectiveness of CYB003 and is set to begin enrolling participants in mid-2024.

In the Phase 2 trial, Cybin reported positive outcomes, with 75% of patients experiencing a remission of depressive symptoms four months after receiving two 16mg doses of CYB003. This success led to the U.S. Food and Drug Administration (FDA) granting CYB003 the breakthrough therapy designation, which could expedite the drug's development process.

CCR's facility in Murray, Utah, will serve as one of the 15 U.S. locations involved in the trial. Dr. Paul Thielking, Numinus' Chief Science Officer, will lead the study as the Principal Investigator. Dr. Thielking expressed enthusiasm about the Phase 2 results, highlighting the drug's potential to treat a condition that impacts over 20 million Americans.

Payton Nyquvest, the Founder and CEO of Numinus, emphasized the importance of 2024 for psychedelic-assisted therapy, with multiple drug candidates advancing in clinical trials. He stated that Numinus is proud to collaborate with drug developers in facilitating research that could lead to FDA approval and improved patient care.

Numinus Wellness Inc. is at the forefront of integrating psychedelic-assisted therapies into mainstream clinical practice. The company is committed to developing and delivering innovative mental health care solutions that prioritize healing over symptom management for a range of conditions, including depression, anxiety, trauma, pain, and substance use.

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