Novartis has reported positive topline data from an ongoing Phase III trial investigating atrasentan in patients with IgA nephropathy (IgAN).
The 36-week interim analysis stated that the trial met its primary efficacy endpoint. Atrasentan demonstrated superiority compared to the placebo in reducing protein in urine, also known as proteinuria.
The reduction was clinically meaningful and statistically significant, according to Novartis’ press release. Atrasentan’s safety profile remains consistent with the data reported from previous clinical trials in IgAN.
Even though the study is still ongoing, Novartis will aim for accelerated approval. According to the announcement, the company plans to review interim results with the US Food and Drug Administration (FDA) to enable potential regulatory submission in 2024.
The Phase III ALIGN trial (NCT04573478) has randomised 340 patients with biopsy-proven IgAN into once-daily 0.75mg dose of atrasentan or placebo for over two years. Throughout the trial, participants will continue to receive supportive care, which is a stable dose of renin-angiotensin system (RAS) inhibitor.
The secondary and exploratory endpoints are evaluating change in kidney function at week 136 as measured by estimated glomerular filtration rate (eGFR), as well as safety and tolerability. The final readout from this trial is expected in Q1 2026.
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Novartis’ kidney pipeline
Atrasentan is an oral endothelin A receptor antagonist. The investigational drug was recently added to Novartis’ portfolio following the acquisition of Chinook Therapeutics for more than $3.2bn.
Alongside atrasentan, Novartis acquired zigakibart, a subcutaneous monoclonal antibody that targets a proliferation-inducing ligand (APRIL). In July, the antibody’s previous owner Chinook dosed the first IgAN patient with zigakibart in a Phase III trial.
Novartis is aiming for another accelerated approval next year. Earlier this month, the company released positive topline data for its iptacopan in IgAN and indicated its plans to submit interim data to the FDA next year. The factor B inhibitor is investigated across multiple indications. In April, iptacopan met the primary endpoint in a Phase III rare blood disorder trial.
Novartis chief medical officer Dr Shreeram Aradhye said: “Along with investigational iptacopan, which recently also showed positive topline Phase III results, and investigational zigakibart, our development portfolio of three highly differentiated late-stage therapies in IgAN has the potential to provide much-needed treatment options for people living with this debilitating disease.”
IgAN is a progressive and rare kidney disease that mostly affects young adults, with an incidence of 2.5 per 100,000 population per year. According to a recent GlobalData report, the IgAN space is likely to see an influx of new potential drugs as there is a large number of products in Phase II or Phase III development.
GlobalData is the parent company of Clinical Trials Arena.