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Novartis' drug has 'potential' to treat C3 glomerulopathy
DTMT Network
Novartis oral experimental drug, iptacopan, has met the primary endpoints in phase two study clinical trial for treating C3 glomerulopathy (C3G), a rare kidney disease, the company said on November 8, 2021.
Iptacopan showed a favorable safety and tolerability profile in phase second final analysis, with no serious adverse events suspected to be related to iptacopan, the statement issued by the company read.
“The data presented at ASN provide a detailed picture of the potential of iptacopan for the treatment of patients with C3G and, for the first time, in patients whose C3G had returned following kidney transplantation,” said lead study investigator Edwin Wong, Consultant Nephrologist at the National Renal Complement Therapeutics Centre, Newcastle upon Tyne NHS Foundation Trust, Newcastle University, UK.
“These results are important for patients with C3G because proteinuria is a key risk predictor for kidney disease progression, and deposits of C3 protein ultimately cause inflammation and kidney damage,” he explained.
C3 glomerulopathy is caused by the over-activation of the complement pathway, which is a part of the human immune system. It leads to the deposition of C3 protein, the most commonly found protein in the blood system and is responsible for destroying invading microbes on the body.
Overactivation of the complementary pathway leads to deposition of C3 proteins on glomeruli -blood vessels that filter waste and remove extra fluids from the blood, leading to inflammation and damage.
Glomerular damage can lead to protein in urine and in severe cases even blood. Various studies have estimated that 50% of the patients risk progressing to kidney failure within 10 years of onset of C3G, the statement added.
“C3G is a devastating disease where people can end up facing life-altering and often exhausting kidney dialysis or transplantation at a time when they might otherwise be focused on building their lives, careers, and families. With currently no approved treatments, there is a major unmet need for therapies that can delay progression to kidney failure,” John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis said.
“These data demonstrate the ability of iptacopan to strongly and specifically inhibit the key driver for C3G – the alternative complement pathway. The results also show the potential for iptacopan to provide the first targeted treatment for people living with C3G, and we are actively recruiting for our pivotal Phase III APPEAR-C3G study,” he added.
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