Vertex releases positive interim analysis results for primary and all secondary endpoints in phase 3 trial of Povetacicept

Vertex Pharmaceuticals has recently announced their positive new data from a pre-specified Week 36 interim analysis of the ongoing Phase 3 RAINIER trial of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF and APRIL cytokines, in immunoglobulin A nephropathy.

Note that the trial met its primary objective. In the interim analysis population, patients treated with povetacicept achieved a 52.0% reduction from baseline in urine protein to creatinine ratio at Week 36, with a statistically significant and clinically meaningful 49.8% UPCR reduction compared to placebo. The reduction in proteinuria was consistent across all pre-specified subgroups.

In addition, this trial also met its secondary objective. For the first secondary endpoint, patients treated with povetacicept demonstrated a 77.4% reduction from baseline in serum galactose deficient IgA1 compared to an increase of +9.1% in the placebo group, yielding a reduction of 79.3% compared to placebo. For the second secondary endpoint, in patients with baseline hematuria, 85.1% achieved hematuria resolution in the povetacicept treatment group compared to 23.4% in the placebo group, resulting in hematuria resolution of 61.7% compared to placebo.

“The Phase 3 RAINIER 36-week interim analysis results in IgAN are remarkable. With its clinical profile, dosing and administration advantage, and breadth of potential indications, povetacicept demonstrates best-in-class potential and establishes renal medicine as Vertex’s fourth franchise alongside cystic fibrosis, hematology and acute pain,” said Reshma Kewalramani, M.D., FASN, Chief Executive Officer and President of Vertex. “As a nephrologist, I am struck by the rapid, deep and sustained response to povetacicept, as well as the consistency of benefit across all subgroups. These results are important for patients with IgAN and also bring us one step closer to realizing povetacicept’s pipeline-in-a-product promise. We thank the patients and trial investigators for their trust and for making RAINIER the largest and fastest enrolling of any contemporary IgAN trial.”

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phase 3 trial of Povetacicept, Povetacicept, Vertex Pharmaceuticals