Successful PARASOL Collaboration Data Analysis Outcome
| Stock | Dimerix Ltd (DXB.ASX) |
|---|---|
| Release Time | 8 Oct 2025, 8:37 a.m. |
| Price Sensitive | Yes |
Dimerix reports successful PARASOL collaboration data analysis
- Final PARASOL data analysis consistent with broader 2024 analysis
- Potential relationship between 12-month proteinuria and kidney failure risk observed
- Discussions planned with FDA on potential accelerated approval pathway
Dimerix Limited, a biopharmaceutical company developing treatments for kidney disease, has received the final data analysis from the PARASOL collaboration. The analysis, which used a patient population emulating the ACTION3 clinical study, is generally consistent with the broader PARASOL analysis conducted in 2024 that supported the use of proteinuria as an endpoint for FSGS clinical trials. The PARASOL collaboration analysis has further demonstrated that both 'proteinuria percent change from baseline' (continuous variable) and a 'proteinuria responder analysis' may be appropriate for use as primary endpoints at 104 weeks in the US. Additionally, the analysis identified a potential relationship between proteinuria at 12 months and subsequent risk of kidney failure. Dimerix and its US partner, Amicus Therapeutics, intend to seek feedback from the FDA on these new PARASOL findings, prior to completing the planned blinded analysis of the ACTION3 data, to align on 104-week endpoints and any potential accelerated approval submission. Dimerix continues to work with its commercial partners across key territories to determine the potential for alternative approval pathways outside of the US.
Dimerix and Amicus Therapeutics plan to seek FDA feedback on the PARASOL findings and potential accelerated approval submission, prior to completing the planned blinded analysis of the ACTION3 data.
Dimerix and its US partner, Amicus Therapeutics, intend to seek feedback from the FDA on the new PARASOL findings in the coming months, prior to completing the planned blinded analysis of the ACTION3 data, to align on 104-week endpoints, as well as any potential accelerated approval submission. Dimerix continues to work with its commercial partners across key territories to determine the potential for alternative approval pathways outside of the US.