MorphoSys AG, a German biopharmaceutical company that focuses on cancer and autoimmune disease therapies, has announced that the first patient in the Phase 2 IGNAZ clinical trial has been dosed with felzartamab, an experimental drug for treating patients with Immunoglobulin A Nephropathy (IgAN). 

The main objectives of the randomized, double-blind, placebo-controlled trial, with study sites in Europe, North America, and the Asian Pacific, are to evaluate the safety and efficacy of felzartamab in patients with IgAN, as well as determine the appropriate dosage. 

Researchers will be looking for relative changes in the ratios of urine protein to creatinine at the trial participants’ nine-month follow-up. 

What Does IgAN Do to the Body?

Immunoglobulin A nephropathy (IgAN), also called Berger’s disease, is a chronic autoimmune disease. It’s the most common form of glomerulonephritis, a group of renal disorders that causes damage to the filtration units (glomeruli) of the kidney. 

Combined genetic and environmental factors cause patients to produce IgA1 antibodies that are deficient in the sugar galactose. In response to the galactose deficiency, the immune system produces specific auto-antibodies, proteins that mistakenly target your own organs and tissues. 

The interaction and binding of these antibodies and autobodies creates molecules that circulate in the blood, causing inflammation, glomerulosclerosis (scarring of kidney blood vessels), and loss of renal function. Patients with IgAN may also experience:

• Blood and/or protein leaking into the urine
• High blood pressure
• Interstitial lung disease
• Slow progression to chronic kidney disease

Approximately 40% of IgAN patients progress to end-stage kidney disease within 20 years of receiving their diagnosis. 

How Is Felzartamab Supposed to Help?

In IgAN, plasma cells foster the development and progression of the disease through the overproduction of IgA1 and its autoantibodies. CD38-positive plasma cells are the main source of autoantibodies in autoimmune diseases. Felzartamab is a human antibody that selectively kills cells that overexpress CD38. In doing so, the drug can potentially deplete the CD38 cell population, and improve patients’ kidney function.

“We believe felzartamab could have great potential as a targeted therapy for patients with autoimmune renal diseases who currently have limited treatment options,” said Mikhail Akimov, MD, Senior VP and Global Head of Drug Development at MorphoSys. “Dosing of the first IgAN patient is an exciting milestone for MorphoSys, physicians and patients alike as we are rapidly broadening our development program for felzartamab.”

*MorphoSys Group. (2021, Oct. 21). First Patient Dosed in Phase 2 IGNAZ Study of Felzartamab in Patients with Immunoglobulin A Nephropathy [Press Release]. Pipeline Review.   https://pipelinereview.com/index.php/2021102179471/Antibodies/First-Patient-Dosed-in-Phase-2-IGNAZ-Study-of-Felzartamab-in-Patients-with-Immunoglobulin-A-Nephropathy.html