Bright Minds Biosciences is offering a new clinical trial opportunity for the PWS community with the launch of their Phase 2 clinical trial in Australia, set to begin in Q1 2026.
PWFR AUS & PWSA AUS will keep families updated as enrolment opens.
Bright Minds Biosciences has launched a Phase 2 clinical trial in Australia, exploring a new oral treatment aimed at reducing hyperphagia and behavioural symptoms in Prader-Willi Syndrome in adults.
The trial will evaluate the new oral medication as a possible treatment for Prader-Willi Syndrome. This randomised, double-blind, placebo-controlled study will assess the drug's efficacy, safety, and tolerability in adult PWS patients.
This proof-of-pharmacology clinical study is designed to evaluate a new potential oral treatment's utility in addressing both hyperphagia (excessive hunger) and the behavioural and neuropsychiatric symptoms of PWS.
This is the first Australian clinical study of this investigational treatment for PWS.
The study will run for approximately 4 to 5 months. At the conclusion of this initial study period, participants may have the opportunity to enrol in a 9-month extension study.
The study is registered on clinicaltrials.gov, where full details are publicly available for review.
A randomised, double-blind, placebo-controlled 16-week study followed by an optional open-label extension.
Total double-blind phase: 16 weeks. An optional 9-month open-label extension follows, where all participants receive the active study treatment.
Contact your local study site or PWS healthcare provider for more information. The criteria below are a guide — a member of the study team will be able to answer your specific questions.
Contact your local study site or PWS healthcare provider for more information about eligibility. Full inclusion and exclusion criteria are available on clinicaltrials.gov.
The NOVA trial is being conducted at two specialist clinical sites in Sydney and Melbourne.
Bright Minds Biosciences looks forward to working with PWS clinicians and advocacy groups to bring this important research to families across Australia.
Reach out directly to a study site in Sydney or Melbourne, or contact PWFR AUS or PWSA AUS to register your interest and be kept updated as enrolment opens.