Psilocybin clinical trial update

FOR PUBLIC RELEASE
NZX Limited
Wellington
21 January 2025
Rua Bioscience Supports Groundbreaking Clinical Study on Psilocybin to Treat
Methamphetamine Addiction
Rua Bioscience is proud to announce its support for a world-leading clinical study that
harnesses the potential of psilocybin-containing mushrooms to treat methamphetamine
addiction. This pioneering research, rooted in an indigenous community and guided by
mātauranga Māori, has reached a significant milestone.
Over the past week, the first cohort of marae-based participants engaged in preparatory
and experiential sessions with mushroom extract containing a specific dose of psilocybin
at Rangiwaho Marae, near Gisborne. This marks an important step in Phase I of the trial.
Dr. Patrick McHugh, lead investigator and addictions specialist at Mātai Medical
Research Institute, explained the three-step process undertaken by participants. "The
first step involves preparation, followed by an experiential session with the taonga
(mushroom). The final and ongoing phase is integration—bringing the experience into
everyday life over the coming weeks and months," said Dr.McHugh.
Learnings from this first phase will guide the next steps, focusing on the intervention’s
safety, acceptability, feasibility, and alignment with tikanga and mātauranga Māori.
Anna-Leigh Hodge, a registered health psychologist from the University of Auckland and
researcher in the study, emphasised the importance of reflection during this phase.
"Throughout Noho Puku (Phase I), we are collectively evaluating what we have learned
and what can be improved. This ensures the wellbeing and mana of participants,
facilitators, and the broader community are upheld".
Collaborative Effort Rooted in Tikanga Māori
The study, named Tū Wairua (standing with strength and spiritual connectedness),
represents a groundbreaking collaboration among Rangiwaho Marae, Rua Bioscience,
and other research and health organisations. The initiative blends local Māori knowledge
MARKET UPDATE

with cutting-edge scientific research to explore the therapeutic potential of indigenous
Psilocybe fungi (taonga).
Tu Wairua is undertaking cultivation trials of taonga varieties with the support from Rua
Bioscience and Manaaki Whenua Landcare Research and the Institute of Environmental
Science and Research (ESR) is providing analytical support. The psilocybin used in this
trial was supplied by Canadian company Optimi Health.
“This initiative is a profound example of the reclamation of mātauranga Māori,” said
Jody Toroa, a trustee of Rangiwaho Marae. “Rangiwaho Marae holds the mauri for this
kaupapa as we contribute to the development of an oranga (wellbeing) model to support
whānau dealing with addiction and historical trauma.”
Marae-based kaitieki (guides) have been trained in collaboration with kaupapa Māori
and psychedelic therapy trainers to provide culturally informed support for participants
throughout the trial.
A Vision for the Future
Rua Bioscience CEO Paul Naske underscored the significance of the initiative. "We are
incredibly excited to be on this journey. Through the Tū Wairua collaboration, we aim to
explore the potential of taonga varieties to benefit individuals and communities alike. By
integrating indigenous knowledge and scientific research, this initiative paves the way
for innovative approaches to health and wellness, with mana whenua leading the
process."
Phase I of the study received full approval earlier this year from both the Health &
Disability Ethics Committees (HDEC) and the Standing Committee on Therapeutic Trials
(SCOTT).
The research team is currently fundraising for Phase II of the clinical trial, which will
expand upon these early findings.
ENDS  
 
The person who authorised this announcement:

Paul Naske
Chief Executive Officer
paul.naske@ruabio.com
+64 21 445154