(CTN News) –drug being studied to treat a rare kidney disease received positive interim results from Novartis on Monday.
the treatment, significant clinical results over a nine-month period in a study, called APPLAUSE-IgAN, for patients with immunoglobulin A (IgA) nephropathy, or IgAN.
There is a rare autoimmuneknown as IgAN that mostly affects young adults and can cause kidney disease failure as a result.
It is expected that the study will continuemonths. There will be approximately 450 adult patients who are at high risk of progression to renal failure as a result of primary part of this project.
As stated by the company, Iptacopan had, in the interim results, “demonstrated superiority to placebo in the reduction of proteinuria (protein in urine) and provided a clinically meaningful reduction in proteinuria that was highly statistically significant”.
According to the Swiss group, it intends to submit the results to the US drug agency, the FDA,for an accelerated approval process.
Each year, about 25 outpeople around the world are diagnosed with IgAN.
According to Novartis, IgAN, a condition in which there is an autoimmune reaction to a variation of IgA, results in the formation of immune complexes that deposit in thecausing progressive damage and eventual kidney failure.
There is evidence to suggest that up to 30% of people who have IgANhigh levels of proteinuria will suffer kidney failure within the next 10 years as a result of the condition.
In a market commentary, Stefan Schneider, an analyst at Vontobel, said that Iptacopan can be seen as a pipeline contained within a tablet.
As a result of the treatment, he said that paroxysmal nocturnal hemoglobinuria had already shown positivea rare characterized by sudden, often nocturnal outbreaks of red blood cell destruction.
Based on Schneider’s estimate, the peak sales potential of thedrug is estimated to be $2.7 billion – $1,7 treat IgA nephropathy.
As part of its ongoing research, Novartis is developing Iptacopan for several rare diseases, including paroxysmal nocturnal hemoglobinuria, IgA nephropathy, and C3 glomerulopathy.
In a recent announcement, the Food and Drug Administration (FDA) has granted therapeutic breakthrough status to this treatment.
It has been reported that Novartis shares are up 0.35 percent in early trading on Monday, with the overall market adding 0.48 percent to 94.20 Swiss francs ($103).