Improving the well-being of many more people around the world struggling with their mental health.
The world is not always a happy place for people. Even before COVID-19, the prevalence of mental health issues among adults and in particular young adults has worsened. Globally, an estimated 320 million people now suffer from depression and anxiety. While that number is expected to rise, the development of novel psychiatric medications is declining and innovation has stalled. This has called for a different perspective on the treatment of mental disorders to which we want to make a meaningful contribution.
A PARADIGM SHIFT
A number of early academic studies performed over the last decade has demonstrated the potential of psilocybin-assisted therapy. In these studies, it was observed that psilocybin provided rapid reductions in symptoms of depression after a single high dose. For a number of patients the antidepressant effects lasted six months or longer. In addition, the studies suggested that psilocybin is generally well-tolerated and has the potential to treat depression when combined with psychological support.
A strong grass-roots movement of non-profits and patient advocacy groups backed by a more general acceptance of the safety profile of psilocybin and a growing recognition of the potential therapeutic value, has since created a paradigm shift in psychiatric R&D towards psychedelics-assisted treatment.
This accumulating body of evidence of the beneficial effects of psilocybin has also prompted, amongst others, the FDA and the US Drug Enforcement Administration (DEA) to permit the use of psilocybin in clinical trials for the treatment of a range of psychiatric conditions, several of which are currently in progress. At the same time, we see that in several jurisdictions psilocybin is in an advanced stage to getting potential approval as a means of medical treatment.
THE CANNABIS PARALLEL
In countries like Canada, Australia and certain states in the US, the legalisation of cannabinoids for recreational use boosted the changing debate about hemp, weed and cannabis as a natural alternative for treatment of various mental diseases. We believe that legalisation of psychedelic truffles in such leading jurisdictions, would boost a similar debate about psilocybin. The first steps in that direction have recently been taken. In the US, the cities of Oakland (CA) and Denver (CO) have already decriminalized psilocybin. Late 2020, the state of Oregon became the first US state to legalize psychedelic fungi. The measure permits supervised use statewide and allows psilocybin to be stored and administered at licensed facilities and used in therapeutic settings.
Like cannabinoids, treatments with psychedelic truffles can become an alternative for conventional pharma-type interventions which are falling short. Not only that, we believe our 100% naturally grown products can also be a better alternative for synthetically created psilocybin currently used in various clinical trials.
Research aimed at exploring the mental health effects of psychedelic truffles or natural psilocybin versus synthetic psilocybin has been fairly limited. Some researchers do suggest that the compounds in psychedelic fungi may work together, much like the varying chemical components of cannabis, to form an entourage effect and that their healing power might be diminished when psilocybin is taken on its own.
RESEARCH AND CLINICAL TRIALS
We strongly support further academic research and (sponsored) clinical trials for psychedelics-assisted treatments. We would particularly encourage more clinical trials using truffle parts or natural psilocybin. Based on many years of collected customer feedback, we believe the most promising areas to further explore are schizophrenia, post-traumatic stress syndrome (PTSS), agoraphobia, attention deficit hyperactivity disorder (ADHD), various eating disorders and palliative care.
Another research angle worth further exploring, is the optimal dosing of psilocybin. We have partnered with Universities in the Netherlands as their sole supplier for a phase 1 clinical trial on this topic. The research showed that the self-rated effectiveness of micro dosing to alleviate symptoms of a range of mental and physiological diagnosis is higher than conventionally offered treatment and lower than macro dosing.