Dimerix provides key update and appointment

Dimerix (ASX: DXB), a biopharmaceutical company, has announced progress on Project PARASOL and appointed Dr. Laura Mariani to its Medical Advisory Board. The project supports the use of eGFR and proteinuria as endpoints for FDA approval in FSGS treatment.

Dimerix's strategic focus and future outlook

Dimerix has made significant progress in its efforts to treat FSGS, a rare kidney disease, through Project PARASOL. The project, a collaborative international effort, confirmed the relationship between improved eGFR and reduced kidney disease risk, supporting eGFR as an endpoint for FDA approval. Proteinuria has also been identified as a potential endpoint, subject to further validation. Dimerix is conducting the ACTION3 Phase 3 clinical trial, with DMX-200 as the investigational product. A blinded interim analysis is planned for mid-2025. The company has also strengthened its Medical Advisory Board by appointing Dr. Laura Mariani, an expert nephrologist. Looking ahead, Dimerix aims to engage with the FDA to finalize proteinuria endpoints for its study, advancing its goal to address the unmet medical need in FSGS treatment.

Executive commentary on strategic advancements

The correlation between improved eGFR and reduced risk of end-stage kidney disease supports eGFR as a surrogate endpoint for FDA approval. The strong relationship between reduced proteinuria and decreased risk of kidney disease progression also suggests that proteinuria could be used as a validated endpoint for full FDA approval, subject to confirmation.