While many publicly-listed psychedelic companies remain in the pre-clinical stage of psilocybin therapeutic development, private company Wake Network is leaping in front of many competitors. The mycology company exploring the pharmacological benefits of psilocybin microdosing and genomics-based integration therapies is soon going into phased clinical trials—and they’re doing it the way nature intended.
On May 12, Wake Network announced that it had received conditional ethics board approval from the Ministry of Health and Wellness in Jamaica to conduct a Phase 2b psilocybin microdosing clinical trial together with the University of the West Indies. The receipt of this ethics board approval is the final step toward securing conditional approval to begin the report.
Beyond the individual significance achieving such a milestone entails, it was also significant to the research community as a whole. As the company describes it, the study, once actualized, will mark the “world’s first psilocybin microdosing trial to be conducted using a randomized, placebo-controlled, double-blind method with mushroom-based psilocybin.” The study is tasked to provide insights into the effects of psilocybin microdosing on people with anxiety and depression.
According to Wake Network Chief Scientific Officer Olga Chernoloz, the trial will actually be a first of its kind on two fronts:
It’s going to be a first trial of its kind, worldwide, and first in two ways. So it’s going to be a microdosing trial using mushroom-based substance. And to date, there are no—as in zero studies—looking at microdosing psilocybin. So we’re going to be (the) first ones really putting psilocybin microdosing through rigor of registered clinical research. And more than that, all the prior studies with psilocybin were done with a synthetic substance, whereas we know that the community of microdosers, none of them are using synthetic substance, because there is no market for it.
Thus, Wake Network will have an opportunity to become a research leaders by heading into advanced clinical trials in an important subset of pharmacological inquiry. After all, the need for an all-natural, low-dose psilocybin therapeutic option in users with mild-moderate depression/anxiety (subclinical) and not requiring assisted psychotherapy is expansive. To date, most Phase 2 psilocybin studies involve mind-altering doses of the drug, along with corresponding psychotherapy.
Click on the embedded link for more of our new interview with Wake Network Chief Scientific Officer Olga Chernoloz, in her own words.