World's Richest Man Says Psychedelics Could Make a Real Difference in Mental Health - Seite 2

In May 2022, Cybin announced that it had submitted an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for its Phase 1/2a first-in-human clinical trial evaluating CYB003. Cybin has hired Clinilabs Drug Development Corporation to carry out the Phase 1/2a clinical trial. Clinilabs is a global full-service contract research organization with deep expertise in central nervous system drug development.

On June 7, Cybin announced that it has entered into an agreement to acquire a Phase 1 study of N,N-dimethyltryptamine (DMT) from Entheon Biomedical Corp. to accelerate the clinical development of CYB004, Cybin's proprietary deuterated DMT molecule for the potential treatment of anxiety disorders. The purchase price for the acquisition is C$1 million. Up to an additional C$480,000 is payable for consulting services to be provided by Entheon up to twelve months after the closing of the acquisition.

The CYB-004-E Phase 1 study (formerly named EBRX-101), is being conducted in the Netherlands at the Center for Human Drug Research, a leading independent foundation specializing in innovative clinical drug research. With 50 healthy volunteers who smoke tobacco, this is the largest Phase 1 DMT clinical study conducted to date. Pending the closing of the acquisition, the CYB004-E study is expected to provide critical safety and dosing optimization data and will replace Cybin's planned pilot study for CYB004 which was scheduled to begin in the third quarter of 2022. Entheon will continue to support the CYB004-E study and act as an external consultant to Cybin.

For more information about Cybin Inc (NYSE:CYBN) (NEO:CYBN), click here.

Other Companies Are Developing Innovative Treatments for Mental Health Issues

Mind Medicine (MindMed) Inc (NASDAQ:MNMD) (NEO:MMED) has announced that Dr. Friederike Holze and Prof. Dr. Matthias Liechti, MindMed collaborators at University Hospital Basel (UHB), will present the results of the LSD-Assist study, a Phase 2  investigator-initiated clinical trial of LSD in the treatment of anxiety disorders, at the London's PSYCH Symposium on May 11, 2022. The presentation, titled "LSD as a Treatment for Anxiety Disorders: New Evidence of Efficacy", will present important preliminary safety and efficacy results of lysergic acid diethylamide (LSD) in 46 patients dealing with clinically significant anxiety.