Clinical Trials

Clinical Trials

Drug Science is a UK organisation that works to provide evidence-based R&D, and equipping the public, media and policy makers with the knowledge and resources to enact positive change. Drug Science is the only completely independent, science-led drugs charity, uniquely bringing together leading drugs experts from a wide range of specialisms, united with a passionate belief that the pursuit of knowledge should remain free of all political interest. Drug Science’s mission is founded on their efforts, and their many hours of work delivering, reviewing, and investigating scientific evidence relating to psychoactive drugs, with one single minded message – to tell the truth about drugs.

Woke has partnered with Drug Science to develop a ground-breaking protocol of a novel high-dose psilocybin, WP-002, with concomitant psychotherapy, for the treatment of treatment-resistant depression. The Drug Science team includes one of the eminent leaders in psychedelics and founder of Drug Science, Dr David Nutt, Professor of Neuropsychopharmacology and Director of the Neuropsychopharmacology Unit in the Division of Brain Sciences at Imperial College London. Professor Nutt is the Chief Scientific Advisor for the WP-002 clinical trial and is an advisor to Woke Pharmaceuticals.

“Professor Nutt and the team at Drug Science are exceptionally knowledgeable and experienced in the design of psychedelic clinical trials. With Drug Science, Woke has designed a ground-breaking Phase IIB trial to evaluate WP002 in patients with treatment-resistant depression.

Macquarie University is a public research university based in Sydney, Australia, in the suburb of Macquarie Park. Founded in 1964 by the New South Wales Government, it was the third university to be established in the metropolitan area of Sydney. Woke and Macquarie signed a non-binding Letter of Intent in August 2021, followed by a formal agreement in April 2022 to conduct a ground-breaking Investigator Initiated clinical trial of a novel low-dose psilocybin, WP-001, to treat moderate depression. The Principal Investigator is Dr Vince Polito, a Senior Research Fellow in the Department of Cognitive Science, has focused much of his work on investigating the ways that altered states and, in particular, psychedelics might impact consciousness and cognition. This Phase IIB trial for the treatment of moderate depression has been designed to evaluate the safety and efficacy of Woke’s WP001 psilocybin drug candidate. The team supporting this study has the skills, experience, and capacity to successfully implement the project plan. If the results are consistent with preliminary studies, this world-first clinical trial may provide important new opportunities for the safe and effective treatment of mood disorders.

“Macquarie University's Dr Polito is a leading clinician in the field of microdosing psilocybin and has assembled an exceptional interdisciplinary team that includes several of the most experienced psychedelic researchers within Australia, to conduct this Phase IIB trial of Woke’s WP001 for treatment of moderate depression.”