Partnership to advance development of psychedelics for depression, anxiety

A clinical-stage biopharmaceutical company and a global contract research organization have partnered to support the ongoing development of investigational, psychedelic therapeutics to treat a range of psychiatric disorders.

Toronto-based Cybin is developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder, as well as CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder, according to a press release from the company.

Worldwide Clinical Trials works with biotechnology and pharmaceutical companies to create customized solutions to advance new medications. Its collaboration with Cybin is expected to enhance study designs — including the current phase 2 trial of CYB003 and any future clinical trials — and global regulatory strategy and aid in navigation of regulatory pathways, per the release.

“We are proud to align with Worldwide, a distinguished [contract research organization] with a proven track record of supporting industry-sponsored psychedelic clinical trials,” Cybin CEO Doug Drysdale said in the release. “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.”

Worldwide recently managed 11 psychedelic studies in psychiatric populations, including phase 1 and 2 trials conducted in the U.S., Canada, U.K. and other European countries, across a range of compounds and treatment models, according to the release.

“At Worldwide, we share a passion for Cybin’s mission to revolutionize mental health care,” Michael Murphy, MD, PhD, chief medical and scientific officer of Worldwide Clinical Trials, said in the release. “We are proud to partner with such a diverse and extraordinary group of experts to help create safe and effective psychedelic-based therapies.”