Early in March, Retrophin, Inc. announced plans to launch a phase 3 clinical trial to evaluate a potential therapy for FSGS patients. The therapy, called Sparsentan, successfully completed a phase 2 clinical trial in 2016 with promising results. The phase 2 clinical trial, known as the DUET Trial, showed a significant decrease in proteinuria for patients that received the therapy, and a greater proportion of patients that received Sparsentan during the trial reached partial remission.
Retrophin plans to launch the phase 3 trial in the second half of 2017. Phase 3 clinical trials are meant to demonstrate the effectiveness of a drug to determine how valuable it may be in clinical practice. It is the last step of research before a drug becomes approved by the FDA for clinical use.
The company is currently working with the FDA to approve the protocol for the clinical trial, which includes using the reduction of proteinuria as an endpoint to demonstrate the therapy’s effectiveness. If approved, Sparsentan would be the first FDA-approved drug for FSGS patients.
NephCure will be working closely with Retrophin to bring awareness to this clinical trial and help bring the patient perspective to their research.
To learn more about Retrophin, Inc. and Sparsentan, click here.
To learn more about ongoing studies, click here.