Novartis is seeing promising results from its substantial $3.2 billion investment in Chinook Therapeutics. Exciting top-line data from a phase 3 trial has demonstrated significant improvements in a key marker of kidney disease, putting the Swiss pharmaceutical giant in a prime position to seek accelerated approval from the FDA in the coming year.
Chinook had already advanced their candidate, atrasentanāan oral endothelin A receptor antagonistāto the brink of phase 3 trials when Novartis came knocking earlier this year. The anticipated release of pivotal data on atrasentan in the fourth quarter provided an early litmus test of Novartis’ strategic move to incorporate it into their pipeline focused on IgA nephropathy (IgAN).
The initial results are indeed promising. Novartis recently disclosed that the phase 3 clinical trial hit its primary endpoint during an interim analysis. In the trial, approximately 340 patients diagnosed with IgAN, a rare and progressive chronic kidney condition, were randomly assigned to receive either atrasentan or a placebo. At the 36-week interim evaluation, Novartis observed a substantial and clinically meaningful improvement in proteinuria, a key indicator of kidney disease, in the atrasentan group compared to the placebo group. This improvement was not only clinically significant but also highly statistically meaningful, successfully meeting the primary trial objective. Furthermore, the safety profile of atrasentan remained consistent with data from an earlier midphase study, with no reports of treatment-related serious adverse events, reinforcing the drug’s safety.
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Buoyed by these promising outcomes, Novartis is gearing up to seek accelerated FDA approval in the United States next year. The company will continue to monitor the kidney function of participants for a total of 136 weeks to generate comprehensive data that supports full approval. Novartis anticipates delivering top-line results from the confirmatory endpoint analysis in the first quarter of 2026.
These phase 3 findings mark a positive milestone for Novartis in the realm of IgAN. Earlier in October, the company reported favorable phase 3 data for iptacopan, an oral factor B inhibitor that was already in its pipeline when it acquired Chinook. Novartis plans to file for accelerated FDA approval for iptacopan next year. In addition to atrasentan and iptacopan, Novartis possesses a second promising IgAN asset, zigakibart, which is also progressing through phase 3 trials.
