Psychedelic therapy developer Cybin Partners has hired Worldwide Clinical Trials to run studies of CYB003, its candidate treatment for major depressive disorder.
The contract – financial terms or which were not disclosed – has already seen WCT lead development of study designs, defining global regulatory strategy and navigation of regulatory pathways, and pharmacovigilance according to Cybin.
CEO, Doug Drysdale, said “We are proud to align with Worldwide, a distinguished CRO with a proven track-record of supporting industry-sponsored psychedelic clinical trials.
“Worldwide brings significant regulatory, logistical, and operational expertise as a leader in psychedelic clinical research, making Worldwide the ideal partner for navigating the regulatory landscape surrounding the development of psychedelic-based therapeutics.”
The clinical research organization (CRO) claims it recent experience managing 11 psychedelic studies in psychiatric populations, including Phase I and Phase II trials in the US, Canada, UK and other European countries, across a range of psychedelic compounds and treatment models.
CYB003 is a proprietary molecule derived from psilocybin, which is part of a family of molecules called indolamines that includes more common neurotransmitters like serotonin.
The product is being evaluated for the potential treatment of Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD) and, according to Canada-based Cybin, is the first ever deuterated psilocybin analog to enter clinical development.
The partnership is one of several major collaborations WCT has set up in recent months. In May, for example, it established new relationships with Spain’s Next Oncology – which has sites in Madrid and Barcelona - and research site organization Pratia Research Platform, which has facilities in Bulgaria, the Czech Republic, Germany, Poland Spain, and Ukraine.
And a week earlier, WCT teamed with Every Cure to use artificial intelligence (AI) to make clinical trials processes more efficient.
In the psychedelics space WCT has previously worked with Psilera, a Florida-based biotechnology company specializing in the clinical development of psychedelics and analogues.