
Australian biotech Dimerix Limited (ASX: DXB), which has a Phase III clinical asset in kidney disease, announced that the final data analysis by the PARASOL collaboration with Dimerix has been received.
This analysis of observational data from major renal registries was conducted to provide Dimerix with further rationale to support the choice of proteinuria endpoints at 104 weeks for the ACTION3 study for potential marketing approval in the USA. In addition, the analysis explored the relationship between proteinuria endpoints at 12 months and the subsequent risk of kidney failure and eGFR endpoints to support a potential application for Accelerated Approval.
The PARASOL analysis used a patient population that emulated the ACTION3 clinical study population (ie, using the major ACTION3 inclusion and exclusion criteria). Pleasingly the results of this analysis are generally consistent with the broader PARASOL analysis conducted in 2024 that supported the use of proteinuria as an endpoint for FSGS clinical trials.
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