Potential FSGS Treatment Option To Be Tested In Phase 3 Clinical Trial April 2, 2017 by Kylie Karley Potential FSGS Treatment Option To Be Tested In Phase 3 Clinical Trial 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.
DUET Study Releases Preliminary Results (SPOILER it looks promising!) September 7, 2016 by Kylie Karley On September 7, 2016, Retrophin Inc. released the “Top Line” results from their recently completed DUET study, a Phase 2 clinical trial testing safety and efficacy of Sparsentan for FSGS patients. Results showed promise for Sparsentan’s effectiveness at reducing proteinuria in patients with FSGS, with one group of patients seeing an average reduction of 44.8%. The DUET study included 96 patients, and only one serious adverse side effect (anemia) was reported. All patients chose to extend their treatment with Sparsentan during the trial’s open label extension period. Alvin Shih MD, the executive vice-president for Retrophin Inc., said “significant reductions in proteinuria, along with a well-tolerated preliminary safety profile have us excited about being one step closer to providing a new treatment option for patients with FSGS.” NephCure Kidney International is excited about these results and support Dr. Shih’s hope that we are moving closer to providing a new, effective, and safe treatment option for FSGS patients. Mark Stone, Chief Executive Officer of NephCure Kidney International, remarked “These preliminary results are very exciting for our community. This gives us hope that better treatment options will be available for our families in the near future.” NephCure Kidney International would like to thank everyone who contributed time, talent, and resources to this study. Thank you, especially, to the patients and families who participated and helped bring effective treatments within reach. Read the official press release here