Psychedelic research has the spotlight. In the midst of the rising tide of IPO’s and RTO’s, and the investor excitement they bring, it can be easy to overlook the nonprofit sector. As enticing as finance can be, these companies are still finding their feet, and their road to profitability will depend largely on the findings of a few very active research institutions and the standardization of clinical practices they’re helping to establish. Truffle Report has previously covered the Johns Hopkins Center for Psychedelic and Consciousness research, the Multidisciplinary Association for Psychedelic Studies, or MAPS, and the Heffter Research Institute. Within recent years, the Usona Research Institute has emerged as a major player, partner, collaborator, and funder of psychedelic research, specifically synthetic psilocybin.
Background on Usona and Partner Institutions/Researchers
Relatively young compared to other major psychedelic research nonprofits, Usona was founded in 2014 as a medical research organization, or MRO, by Bill Linton and Malynn Utzinger, MD, both formerly of Promega Corporation. According to Usona’s website, Linton and Utzinger were inspired to create the institute by the early results from Johns Hopkins University’s study on the effects of psilocybin in treating end-of-life anxiety and emotional distress in cancer patients.
Since then, Usona has grown to a staff of around twenty full-time researchers and consultants, and is involved in funding and collaborating with an impressive number of institutions and individual researchers.
The full list from their site is as follows:
D’Or Institute for Research and Education (IDOR)
Hans Knöll Institute
Imperial College London
Heffter Research Institute
MAPS Public Benefit Corporation
Swiss Neuromatrix Foundation
University of Wisconsin Hospital and Clinics
University of Wisconsin–Madison School of Pharmacy
Michael Bogenschutz, MD, New York University
Robin Carhart-Harris, PhD, Imperial College London
Roland Griffiths, PhD, Johns Hopkins University School of Medicine
Charles Grob, MD, Harbor-UCLA Medical Center
Dirk Hoffmeister, PhD, Friedrich Schiller University and Hans Knöll Institute
Matthew Johnson, PhD, Johns Hopkins University School of Medicine
Benjamin Kelmendi, MD, Yale School of Medicine
Janis Phelps, PhD, CIIS Center for Psychedelic Therapies and Research
Stephen Ross, MD, New York University
Franz Vollenweider, MD, University of Zürich
Joshua Woolley, MD, PhD, UCSF School of Medicine
Psilocybin Clinical Trial for Major Depressive Disorder
Advancing research into psilocybin for major depressive disorder (MDD) is not a quick or easy process. To be done properly, Usona’s current Phase-II study will include eighty participants enrolled from 2019-20. Patients must pass through screening and preparation sessions, be in generally good health, can not currently be taking any steps to treat their MDD, and must have a support person to take them home safely after psilocybin or placebo sessions. Patients will be given a single dose of psilocybin, or the placebo niacin, monitored for 7-10 hours, and treated with multiple integration and assessment sessions in the following weeks.
Extensive research and clinical trials into psilocybin for a variety of mental health indications are underway or have been completed by Usona and other institutes. What’s lacking thus far has been the large-scale, placebo-controlled tests that are essential to moving through FDA regulatory processes before any drug or therapy can be approved, mass-produced, or administered. Recruitment for the psilocybin clinical trials is currently underway at five locations, with two more set to begin soon. Usona’s clinical trial site warns of potential disruptions to the screening and enrollment process due to COVID-19.
Breakthrough Status and Public Domain Psilocybin Synthesis from Usona
It’s great to talk about the partners and work an institution has under its aegis, but the real measure has to be results. Here, Usona stands out with two important headlines in the past year. First was the decision by the FDA to grant their Breakthrough Therapy designation to Usona’s research on psilocybin and the treatment of major depressive disorder. As we’ve previously discussed, MDD is the second largest pharmaceutical treatment market in the world, to say nothing of the profound human impact a more effective treatment might represent.
More recent is their decision to share their processes. Keeping to their philosophy of open science, Usona chose this past September to enter its innovative method for synthesizing psilocybin into the public domain. The production of crystallized psilocybin for research purposes is expensive, and it’s efficiency and standardization are major hurdles for the fledgling pharmaceutical psychedelic sphere to overcome. Usona has shortened that process, with the new procedure being available to any licensed facility with a Good Manufacturing Procedures, or GMP, certification awarded by the US Food and Drug Administration.