Otsuka Pharmaceutical and Visterra, Inc. recently shared developments regarding an innovative drug, sibeprenlimab, targeted at treating immunoglobulin A nephropathy (IgAN), also known as Berger’s disease. The U.S. Food and Drug Administration (FDA) has awarded sibeprenlimab the Breakthrough Therapy designation, underscoring its potential as a significant advancement over existing treatments for this challenging condition. Learn more about sibeprenlimab and its possibilities for helping people living with IgAN.*

What is sibeprenlimab?

Sibeprenlimab is a type of antibody designed to inhibit the function of a proliferation-inducing ligand (APRIL), a protein implicated in the progression of IgAN. By neutralizing APRIL, sibeprenlimab aims to slow the disease’s advancement by reducing harmful immune responses and their resulting kidney inflammation and damage. 

This approach represents a strategic shift toward targeting the underlying mechanisms of IgAN, which is pivotal given its status as a leading cause of kidney failure among young adults.

The ENVISION trial

The optimism surrounding sibeprenlimab stems from the results of the Phase 2 ENVISION trial, which demonstrated promising outcomes in mitigating the effects of IgAN. The Phase 2 trial was a multicenter, double-blind, randomized, placebo-controlled, parallel-group trial involving 155 adults with IgAN who were at high risk for disease progression, despite having already received standard treatment.

The majority of participants were randomized into groups receiving different dosages of sibeprenlimab, while the remaining 38 participants received a placebo. After 12 months of treatment, those who received sibeprenlimab experienced a significantly greater decrease in proteinuria than those who received the placebo.

With the FDA’s Breakthrough Therapy designation, the new drug’s development and review processes will be expedited, facilitating a faster path to potential approval and availability for patients in dire need of more effective treatment options.

What is IgAN?

IgAN, an autoimmune disease, is the most common type of primary glomerulonephritis, a condition characterized by inflammation and damage to the kidneys’ filtering structures. It leads to a decline in kidney function and, in many cases, eventual kidney failure. Despite current treatments, such as renin-angiotensin-aldosterone system (RAAS) blockers to control hypertension, the prognosis for many patients remains grim. The manufacturers say that sibeprenlimab’s development may offer hope for those at risk of progressing to end-stage kidney disease.

“Sibeprenlimab is the first of several precision therapy biologics designed and engineered by Visterra to treat chronic kidney disease patients with major unmet medical needs,” said Brian Pereira, M.D., CEO of Visterra Inc. in the press release. “The results of the Phase 2 trial in patients with IgA nephropathy have been encouraging, and we look forward to completion of the Phase 3 trial and submission of the Biological Licensing Application (BLA) to the US FDA and other global regulatory authorities.”  

*Otsuka Pharmaceutical Co. (2024, February 16). Sibeprenlimab Receives U.S. FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy. https://www.otsuka-us.com/news/sibeprenlimab-receives-us-fda-breakthrough-therapy-designation-treatment-immunoglobulin 

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