The licence is only for cultivation research at this stage. ESR will be providing analytical testing services to determine the levels of psilocybin and other compounds in the fungi to ensure accurate dosing when the time comes to use the mushrooms in human trials.
A statement from the group said psilocybin had shown promise in preliminary studies for treating various mental health conditions, including depression, anxiety and PTSD.
Rangiwaho Marae has been leading the planning for clinical trials involving
rongoā practitioners, medical professionals and psilocybin.
The trials will initially involve healthy adults to demonstrate the safety of psilocybin, but the goal is to help whānau affected by methamphetamine and other addictions.
“We are hugely excited about this opportunity for our whānau,” said Rangiwaho trustee Jody Toroa.
“These taonga are provided by the atua and our people have been using them for healing and wellness for centuries. We have been learning from tohunga about how the taonga can help shift ingrained habits and unhelpful ways of thinking, to open up new possibilities.”
Rua Bioscience chief executive Paul Naske expressed enthusiasm about the new development.
‘World-leading innovation based here’
“It is a privilege to be involved in this groundbreaking project and we are excited to be able to support this kaupapa. It is exciting to see Australia and other jurisdictions embracing innovative and potentially life-changing medical research with psilocybin and exciting for Rua Bioscience to now be part of such a great national collaboration.
“Collaborating with Rangiwaho, ESR, rongoā practitioners and university medical researchers provides us with a unique opportunity to explore cultivation techniques that can contribute to research undertaken in a culturally safe environment with the support of a range of expertise. Bringing together Mātauranga Māori, psychedelic traditions and contemporary neuroscience research is world-leading innovation based here in Tairāwhiti.”
Mr Naske emphasised that this development would add to the botanical pharmaceutical focus of Rua Bioscience. It was cost-neutral and in no way detracted from the commercial priorities of the company which is currently selling cannabis-derived medicines in Europe and Australia.
Project regulatory adviser Manu Caddie said the decision by Manatū Hauora, the Ministry of Health, to grant the cultivation licence reflected a global shift in attitudes towards psychedelic substances and their potential therapeutic value.
“It will help position New Zealand as part of the pioneering group of jurisdictions supporting this evolving research domain.
“Official information provided by Medsafe last month to the New Zealand Drug Foundation showed that no one in New Zealand has been prescribed psilocybin to date in a clinical setting. Three applications have been made for using psilocybin in clinical trials, all in the past 18 months.
“Rangiwaho Marae has received Health Research Council funding to progress the clinical research programme and Rua Bioscience will now begin cultivation trials with the aim of producing consistent levels of psilocybin to be used in clinical trials.”
In March this year Ms Toroa spoke about finding specimens of the indigenous fungi known as weraroa “on our whenua here at Rangiwaho”.
Kay Robin, a Rangiwaho Marae trustee, was the person who found the weraroa.
“It seemed like I was just plodding along after doing a karakia and I said, ‘Hey, could this be it?’ and it was,” she said. “All of us who were there took it as a tohu (sign) that our tīpuna were with us and we were on the right track.”
The weekend before Cyclone Gabrielle, a wānanga was hosted by Rangiwaho for the project members from around the country. The focus was on progressing the plans and learning more about the latest science on psilocybin therapies, fungi research and relevant rongoā processes to be used in the trials.
“It felt serendipitous,” said Ms Toroa. “We all came together from completely different backgrounds and we all just clicked. The kaupapa was driving us and we were all on the same page. It was about how we can get to the next stage and continue to support each other.”
Nine months later that next stage has arrived with the granting of the licence to cultivate the weraroa for research purposes.