new medication for rare form of kidney disease still expected to complete stage iii trial this year
the drug, atrasentan, attracted considerable attention last year when data from an earlier study showed a significant reduction in signs of kidney disease for patients diagnosed with berger's disease (iga nephropathy).
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iga nephropathy (igan) is a condition where buildup of the protein immunoglobulin a (iga) causes inflammation and damage to the kidneys. getty
a new medication to treat a rare form of kidney disease is expected to complete clinical trials later this year despite, representatives from chinook therapeutics said. the fda has suggested the company extend the endpoint of the stage iii clinical trial by three more months for further data collection.
iga nephropathy (igan) is a condition where buildup of the protein immunoglobulin a (iga) causes inflammation and subsequent damage to the delicate structure of the kidneys. this progressive condition affects roughly 1.29 out of 100,000 people annually in the us, and is believed to be impact 1.61/100,000 people per year in canada. as many as 50 per cent of igan patients will reach kidney failure.
chinook therapeutics, a canadian-american drug development company, told attendees at the annual bloom burton & co. health-care investor conference they were looking to release results from their stage three clinical trial this year on their treatment for igan, atrasentan. completing this trial will “really be transformational for the company that we hope will move us from a development organization into that commercial stage,” said tom frohlich, chief operating officer at chinook therapeutics.
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in 2022, the chinook therapeutics attracted attention when they released data from their phase two trial for atrasentan. eleven subjects who received the medication during the non-blinded study had experienced an average of 54.7 per cent reduction in proteinuria after 24 weeks. (proteinuria is a condition in which protein leaks from the kidneys into the blood stream and an indicator of renal damage)
however, it still may take some more time to complete the stage three trial, as the fda has “suggested that we shift our primary endpoint from 24 weeks to 36 weeks to have greater data.” the company has requested a meeting with the fda to confirm the best way forwards, whether that be “maintaining that 24-week primary endpoint and unblinding at 36 weeks or shifting that endpoint from 24 weeks to 36 weeks altogether,” said noopur liffick, senior vice president of investor relations and corporate communications at chinook therapeutics.
atrasentan was initially developed by the company abbvie to reduce the onset of end-stage kidney disease and proteinuria in patients with diabetes. the data collected through the abbvie research allowed chinook to accelerate the clinical trial process, cutting out years of animal-model studies.
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how is iga nephropathy treated?
iga is released when the body responds to infection, leading researchers to believe this form of neuropathy may be connected to the immune system.
there is currently no cure for igan, however, medications may slow the progression of these conditions. steroids, like methylprednisolone, may help maintain renal function, while blood pressure medications can reduce the amount of protein in the kidneys. last year, the fda granted accelerated approval for tarpeyo, a glucocorticosteroid, for adults at risk of rapid disease progression. filspari, a non-immunosuppressive therapy medication, was also granted accelerated approval by the fda in february 2023.
lifestyle changes are also recommended to reduce blood pressure and lower cholesterol levels, each of which can be hard on the kidneys.
not all treatment plans are successful, and some patients may require dialysis and/or a kidney transplant once the damage to the kidneys becomes too great to overcome. however, a transplant will not necessarily stop the build-up of iga, and a percentage of patients may again find themselves in kidney failure in the years after a successful transplant.
looking forwards, representative of chinook therapeutics also explained to conference attendees they have seen promising data from a stage 1-2 clinical trial in their monoclonal antibody that targets earlier phases of iga neuropathy. they intend to start phase three clinical trial later this year.
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emma jones is a multimedia editor with healthing. you can reach her at emjones@postmedia.com or on instagram and twitter @jonesyjourn.
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