Alira Health, a global advisory and clinical research firm, announced today its collaboration with the Scottsdale Research Institute (SRI) to provide comprehensive regulatory and clinical support with the goal to bring clinical research of psilocybin to the State of Arizona. The partnership will provide strategic guidance and support in regulatory strategy, regulatory submissions, regulatory monitoring, clinical trial design and clinical operations.
In 2023, a diverse coalition of military veterans, firefighters, and Arizonans with terminal illness pushed for the legislature to approve the $5 million for natural psilocybin research. This research will be funded through a grant program administered by the Psilocybin Research Advisory Council at the Arizona Department of Health Services (ADHS).
ADHS oversaw a rigorous procurement process and ultimately awarded SRI funding to conduct the first controlled study of psilocybin mushrooms in humans, a Food and Drug Administration (FDA) Phase 1/2 trial in patients with life-threatening illnesses.
If approved to proceed with testing in human subjects by both the FDA and Arizona State University's Institutional Review Board (IRB) committee, Arizona will be the first state in the United States to host an Investigational New Drug (IND)-enabled randomized controlled clinical trial utilizing whole mushrooms to administer psilocybin. SRI hopes this trial will contribute to the base of scientific evidence regarding the potential use and efficacy of psilocybin treatment for patients with various health conditions, including chronic pain, post-traumatic stress disorder (PTSD), long COVID, obsessive-compulsive disorder (OCD), depression autoimmune disorders, and terminal illnesses.
Funding from the State of Arizona will support SRI's pursuit of clinical approval and provide a backbone for regulatory oversight, clinical trial implementation, and clinical operations.
Regulatory activities currently underway are funded by a grant program established by the newly created Psilocybin Research Advisory Council. The council will also advise the governor and the legislature on the use of psilocybin in medical treatment.
“We are pleased to be part of a groundbreaking initiative that has the potential to revolutionize mental health treatment," said Gabriele Brambilla, CEO of Alira Health. "Our team of regulatory and clinical experts will work closely with SRI to navigate the complex landscape of drug development and ensure that these clinical trials are conducted with the highest standards of safety and efficacy.”
“The state of Arizona is on the cusp of becoming a world leader in conducting first ever studies of natural psilocybin mushrooms in FDA controlled trials,” said Dr. Sue Sisley, President of SRI. “Whole psilocybin mushrooms, with all of the molecules working together, could offer superior healing potential than one synthetic molecule, which is the only study drug currently being examined.”
