Enveric Biosciences is partnering with the University of Calgary to study its first-generation psychedelic treatment EVM-101 in patients with cancer-related distress (CRD).
Later this year, the University of Calgary's Hotchkiss Brain Institute, led by Valerie Taylor, the head of its psychiatry department, will work with Enveric to explore the effects of EVM-101 in CRD patients. The study will build on earlier work that suggests psilocybin, the main active ingredient in magic mushrooms, can help people with the condition.
“Based on several pilot studies conducted at different academic centers, psilocybin at a dose range of 25-30 mg, in association with support therapy, demonstrated significant benefit in cancer patients with CRD,” said Bob Dagher, chief medical officer at Enveric.
A 2018 study found 52% of the 3,724 tested cancer patients had high levels of psychological distress, with fatigue and sleep problems among the most common issues. Other groups have run randomized clinical trials to explore the idea that psilocybin can help alleviate depression and anxiety in cancer patients, generating the data that encouraged Enveric to move its candidate into clinical development.
As in other clinical trials of psychedelic medicines, EVM-101 forms part of a broader therapeutic support package in the study planned by Enveric and the University of Calgary. The psychedelic experience is the centerpiece of a process designed to help patients prepare for and then integrate what happens when they take the therapy.
“Cancer participants who enter the EVM101-201 study will receive supportive therapy that includes education on the role of psilocybin on inducing a psychedelic mind-manifesting experience, preparation for the dosing session, support during the dosing day, and post-dose integration therapy to explore the resulting effects on the participant's experience, mental status changes, and symptomatology,” said Dagher.
Enveric acquired a library of novel derivative psychedelics molecules last year through its acquisition of MagicMed Industries, a Canadian developer of psychedelic-derived medicinal products. The acquisition followed the spinning off of Enveric from AMERI Holdings.
After spinning off, Enveric initially focused on the use of novel cannabinoid medicines to help patients with the side effects of cancer treatments, later expanding into psilocybin and dimenthyltryptamine with the takeover of MagicMed.