15 Jan NEJM: Sibeprenlimab Stabilized Kidney Function Decline in Most Common Glomerular Disease
MedicalResearch.com Interview with:
Mohit Mathur MD, FASN, FNKF, FRCP (Glasgow)
Clinical fellow in Nephrology at UofT
DM (Nephrology), MRCP.UK (SCE in Nephrology).
Director, Clinical Development
Waltham, MA 02451
MedicalResearch.com: What is the background for this study? Would you briefly describe the condition of IgA Nephropathy?
Response: IgA Nephropathy is the commonest primary glomerular disease in the world. It is an autoimmune kidney disease that typically presents with urinary abnormalities, elevated blood pressure and reduced kidney function. Until recently IgAN was considered to be a benign disease, but recent studies have indicated that a majority of patients will progress to End stage kidney disease in their lifetime.
Steroids have been the mainstay of treatment in IgAN, but they come at a very high burden of side effects. Thus, there is an urgent requirement to develop novel and safe treatment options for patients with IgAN. APRIL is considered to be a key cytokine implicated in the pathogenesis of IgAN, hence we decided to target APRIL as a therapeutic modality in IgAN.
MedicalResearch.com: How does Sibeprenlimab differ from other treatments for this condition?
Response: Sibeprenlimab is being developed as a precision therapy in IgAN, which acts by blocking APRIL. Sibeprenlimab blocks the upstream activation of pathogenic cascade in IgAN, unlike other therapies in development which either act broadly by either inhibiting the complement cascade or act as downstream hemodynamic modulators, which leave the upstream immune mechanisms unchanged.
MedicalResearch.com: What are the main findings?
Response: In this Ph 2 trial, sibeprenlimab recipients had statistically significant reduction in proteinuria and stabilization of eGFR decline relative to placebo at a magnitude that has not been seen in other clinical trials in IgAN with an acceptable safety profile.
MedicalResearch.com: What recommendations do you have for future research as a results of this study?
Response: The results from this Ph 2 trial are very encouraging, we are currently running a global Ph 3 study to hopefully confirm these results in a larger patient population.
None, Disclosures: Full time employee of Visterra Inc.
A Phase 2 Trial of Sibeprenlimab in Patients with IgA Nephropathy
Mohit Mathur, M.D., Jonathan Barratt, Ph.D., Bobby Chacko, M.D., D.M., Tak Mao Chan, M.D., D.Sc., Laura Kooienga, M.D., Kook-Hwan Oh, M.D., Ph.D., Manisha Sahay, M.D., Yusuke Suzuki, M.D., Ph.D., Muh Geot Wong, M.B., B.S., Ph.D., Jill Yarbrough, B.A., Jing Xia, Ph.D., and Brian J.G. Pereira, M.D. for the ENVISION Trial Investigators Group
January 4, 2024
N Engl J Med 2024; 390:20-31
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Last Updated on January 15, 2024 by Marie Benz MD FAAD