Dimerix plans FDA meetingDXB actively supports the working group...

Dimerix plans FDA meeting

DXB actively supports the working group and participated in workshops held in June and October 2024.

The October 2024 PARASOL Scientific Workshop, attended by clinicians, patients, key opinion leaders, statisticians, FDA representatives, and industry sponsors (companies), presented preliminary analysis of observational data from FSGS patients globally.

The dataset included a broad demographic range and was not limited to randomised trial data like the DXB ACTION3 Phase 3 clinical trial.

The preliminary analysis, shared at the American Society of Nephrology (ASN) meeting in San Diego on October 25 confirmed a strong correlation between the surrogate endpoint of eGFR improvement and reduced risk of end-stage kidney disease.

DXB said notably eGFR was the current primary endpoint for the ACTION3 trial.

The analysis also proposed that proteinuria may also be an appropriate primary endpoint for full FDA approval. The working group recognised that FSGS patients often retained residual kidney scarring, which may prevent some from reaching low proteinuria levels seen in other kidney diseases.

The PARASOL data showed that higher proteinuria thresholds, including 0.7 g/g, 1.0 g/g, and up to 1.5 g/g, were associated with a reduced risk of progression to renal failure, offering new potential FDA approval targets for FSGS drug candidates.

The FDA expressed general support for the PARASOL data’s correlation between proteinuria reduction and decreased kidney disease progression risk.

However, DXB said each industry sponsor would likely need to justify the chosen proteinuria threshold and demonstrate the biological mechanism of their candidate drug.

DXB said for its ACTION3 Phase 3 clinical trial, and subject to FDA approval, it was likely that the company may now have a range of proteinuria endpoints that could acceptable as primary endpoint for FDA approval.

As both eGFR and proteinuria data are collected over two years, no study changes were expected.

DXB said it planned to request a meeting with the FDA to confirm the proteinuria endpoints for DMX-200 in the ACTION3 trial.