Swiss pharmaceutical company Novartis has published pre-specified interim analysis results from the Phase III APPLAUSE-IgAN clinical trial of Fabhalta (iptacopan) in Immunoglobulin A nephropathy (IgAN) patients.
The randomised, placebo-controlled trial enrolled 518 adult patients with primary IgAN, who were given two oral doses of Fabhalta a day.
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The primary endpoint of the interim analysis is proteinuria reduction at nine months based on the urine protein to creatinine ratio (UPCR), while the final analysis has the annualised total eGFR slope over 24 months as its primary endpoint.
Various other secondary endpoints, including the proportion of participants reaching UPCR <1g/g without receiving other treatments, will also be evaluated in the final analysis.
The interim data indicated that subjects treated with Fabhalta attained a significant 38.3% decline in proteinuria versus placebo, in addition to supportive care.
Treatment with Fabhalta was well-tolerated, with its safety profile in line with prior data.
Data from the primary endpoint for final analysis is expected next year.
Novartis cardiovascular, renal and metabolism development unit global head David Soergel said: “IgAN progresses over many years, and patients’ needs may evolve such that different therapies may be best used at different times.
“Our renal pipeline includes medicines with a variety of mechanisms which may allow them to be targeted to patients based on their clinical characteristics.”
Fabhalta is an investigational Factor B inhibitor of the alternative complement pathway.
The drug was approved by the US Food and Drug Administration (FDA) for adult patients with paroxysmal nocturnal haemoglobinuria (PNH) in December last year.
Last month, it also received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
In October last year, Novartis reported positive data from a Phase III clinical trial of atrasentan in IgAN patients.
