On October 30, Novartis announced that the ongoing ALIGN pivotal Phase III study of its oral endothelin A receptor antagonist (ERA) atrasentan met the primary efficacy endpoint in an interim analysis at 36 weeks.The ALIGN study (NCT04573478) is a global, randomized, multi-center, double-blind, placebo-controlled Phase III clinical trial, with the primary endpoint.It is the change in UPCR from baseline to 36 weeks.
The interim analysis results at 36 weeks showed that in IgAN patients receiving supportive care (maximum tolerated and stable doses of renin-angiotensin system [RAS] inhibitors), atrasentan significantly reduced proteinuria compared to placebo, with clinical significance and high statistical significance, demonstrating the superiority of atrasentan.In this study, the safety of atrasentan was consistent with the previously reported Phase II AFFINITY study IgAN cohort data. Based on the results of this interim proteinuria analysis, Novartis plans to submit an accelerated approval application in the United States in 2024.。The ALIGN study will continue to be assessed in a blinded manner.Changes in renal function measured by estimated glomerular filtration rate (eGFR) over 136 weeks are expected to yield preliminary results of the confirmatory endpoint analysis in the first quarter of 2026.
IgAN is a leading cause of chronic kidney disease and kidney failure, primarily affecting young adults. Up to 30% of patients with IgAN will progress to kidney failure within 10 years, with persistent high levels of proteinuria (≥1 gram/day). Patients with IgAN require effective therapies to slow the progression of kidney failure.
AtrasentanIs an orally active endothelin A receptor antagonist (ERA), byChinook Development: In June this year, Novartis acquired Chinook for $35 to obtain this drug.Phase 2 AFFINITY interim results showed an average reduction of proteinuria by 54.7% at week 24.In addition, the acquisition of Chinook also gained another renal drug.Zigakibart（BION-1301）Zigakibart is a subcutaneously injected anti-APRIL monoclonal antibody, and its Phase III clinical trial for lgAN has been initiated in the second half of this year.
Currently, Novartis has another drug in the nephrology field.Oral Complement Factor B Inhibitoriptacopan(LNP023), PNH, IgAN, C3 glomerulopathy multiple indications progressBy Phase 3, PNH has reached its primary endpoint, and recently, the pre-specified interim analysis primary endpoint was achieved in the Phase III trial for IgAN.。Novartis is advancing the development of these three potential treatment options with different mechanisms of action to address the unmet needs in IgAN and other rare kidney diseases.
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