Research & Development
Initial focus on psilocybin for depression based on evidence of efficacy. Proprietary formulations to enhance release profile of active drug and secure Intellectual Property
WP001 is a low-dose psilocybin drug candidate for treatment of moderate depression. It was formulated with Monash University’s Medicines Manufacturing Innovation Centre (MMIC, VIC), as a novel rapid-release capsule.
In collaboration with Macquarie University, a Phase IIB trial is anticipated to commence in early CY2023. Submission for ethics approval was filed in October 2022. The trial will enrol over 260 patients with moderate depression in a randomised, controlled study. The primary endpoint will be the Grid-Hamilton Depression Score, with secondary endpoints that include biomarkers, physiological and neurophysiological measures.
Patients interested in the Phase IIB trial of WP001 to treat moderate depression should contact email@example.com
WP002 is a high-dose psilocybin drug candidate with concomitant psychotherapy, which has been formulated with MMIC, as a novel rapid release tablet.
A Phase IIB trial in patients with treatment-resistant depression is anticipated to be submitted for ethics approval in late CY2022, then commence enrolment at multiple sites in Australia in early CY2023. The Principal site is Swinburne University, VIC. This trial is being conducted in collaboration with UK-based Drug Science, led by Professor Dave Nutt at Imperial College London. The Phase II trial will enrol approximately 160 patients with treatment-resistant depression in a randomised, controlled study. The primary endpoint will be the MADRS Depression Score, with secondary endpoints that include physiological and neurophysiological measures as well as health economic measures.
With QIMR Berghofer, Woke aims to conduct a feasibility trial of WP002 to treat prolonged grief disorder. The study, named PARTING: Psilocybin-Assisted supportive psychoTherapy IN the treatment of prolonged Grief, will enrol approximately 15 patients with the intention of demonstrating intervention acceptability and proof-of-concept efficacy. The intervention will include three preparatory psychotherapy sessions, one WP002 psilocybin dosing session and six post-experience psychotherapy integration sessions.
With University of Sydney, Woke is planning a 60-patient Phase II randomised, controlled trial to teat patients with alcohol use disorder. Outcomes will be assessed monthly for three months using standard measures for alcohol research approved by the FDA including abstinence and no heavy drinking days. The trial design is being finalised.
Patients interested in the trials of WP002 to treat treatment-resistant depression or prolonged grief should contact firstname.lastname@example.org
WP003 is working with researchers at the University of Western Australia to discover novel analogues of LSD (lysergic acid diethylamide) for treatment of anxiety, substance abuse and other mental health disorders. Through novel chemistry, Woke Pharmaceuticals aims to enhance the efficacy and solve some of the challenges that have limited the therapeutic application of LSD.