- Final patient recruited into Syntara’s randomised, double-blind, placebo-controlled Phase 2 study of first-in-class neuro-targeted anti-inflammatory therapy, SNT-4728, to treat isolated REM Sleep Behaviour Disorder (iRBD).
- iRBD affects around 2% of individuals over 50 years of age, and up to 90% of these patients progress to a neurodegenerative disease, highlighting a substantial unmet medical need.
- In addition to assessing safety, the study is evaluating the ability of SNT-4728 to reduce inflammation in brain regions linked to the progression of various neurodegenerative disorders, including Parkinson’s disease.
- The study is being conducted in collaboration with leading academic centres and is supported by Parkinson’s UK through its Parkinson’s Virtual Biotech program in partnership with the Parkinson’s Foundation
- Top-line results are expected in Q2 CY26, making this one of five Syntara clinical studies with data readouts anticipated during calendar year 2026.
Syntara Limited (ASX: SNT), a clinical-stage drug development company, is pleased to announce that the final patient has been enrolled into its randomised, double-blind, placebo-controlled Phase 2 clinical trial of SNT-4728 in patients with isolated REM Sleep Behaviour Disorder (iRBD), a severe sleep disorder associated with a high risk of progression to neurodegenerative disease. With recruitment now complete and patients undergoing a three-month treatment period, top-line results are expected in Q2 CY26.
iRBD is estimated to affect approximately 2% of people over 50 years of age, and the multi-centre study is evaluating Syntara’s first-in-class neuro-targeted anti-inflammatory therapy in this population. Long-term observational studies suggest that up to 90% of individuals with iRBD subsequently develop a neurodegenerative disease such as Parkinson’s disease or Dementia with Lewy bodies, positioning iRBD as the strongest clinical predictor of these disorders.
The study is designed to evaluate the potential impact of SNT-4728 across two important and complementary dimensions:
- The study includes advanced brain imaging at baseline and after the 12-week treatment period to determine whether SNT-4728 reduces neuroinflammation in key brain regions implicated in the progression from iRBD to Parkinson’s disease and related neurodegenerative disorders
- The study contains an exploratory secondary endpoint to assess whether treatment with SNT-4728 improves the clinical symptoms of iRBD.
Evidence of reduced neuroinflammation on brain imaging would support the broader hypothesis that SNT-4728 has the potential to modify disease biology during the prodromal phase of neurodegeneration. In turn, such findings would represent a meaningful advance in the field and are likely to be of strong interest to Syntara’s existing funding partners, Parkinson’s UK, as well as other philanthropic organisations and pharmaceutical companies.
“A positive outcome from this study could potentially change the field,” said Professor Simon Lewis, Director of the Parkinson’s Disease Research Clinic at Macquarie University. “For patients with iRBD, demonstrating an improvement in symptoms would offer immediate hope in a condition where treatment options are currently very limited. At the same time, evidence that SNT-4728 reduces neuroinflammation in key brain regions would provide important insight into whether intervening at this early (prodromal) stage could influence the processes that lead to Parkinson’s disease and related disorders.”
Syntara Chief Executive Officer Gary Phillips said on the completion of recruitment:
“This has been a complex and logistically challenging study, and I would like to sincerely thank the principal investigators, Prof Simon Lewis and Prof Michele Hu, the study staff and, most importantly, the patients who have participated. Their commitment has made it possible to conduct a trial that addresses fundamental questions about both symptom relief and disease biology in iRBD.
I would also like to take this opportunity to express my thanks to Prof Andrew Scott and his team in Melbourne for conducting nationwide PET imaging for the Australian component of the study. Their unwavering support and dedication made it possible for us to commence the study within a meaningful timeframe.
This trial sits within our broad portfolio of clinical programs, from which we are expecting five data read outs through the course of 2026. Together, these studies have the potential to meaningfully advance our pipeline and inform future development and partnering opportunities.”
The Phase 2 iRBD study is being conducted in collaboration with leading academic centres and is supported by Parkinson’s UK through its Parkinson’s Virtual Biotech program in partnership with the Parkinson’s Foundation, underscoring the strategic importance of targeting neuroinflammation in the earliest stages of neurodegenerative disease.
