Vertex reported a phase 3 win for its kidney disease prospect povetacicept, meeting analyst expectations and firing the starting gun on a race to the FDA that could result in an accelerated approval in November.
The data come from a prespecified Week 36 interim analysis of a trial comparing povetacicept, a dual inhibitor of the BAFF and APRIL cytokines, to placebo in immunoglobulin A nephropathy (IgAN). Vertex posted a 49.8% reduction in the urine protein to creatinine ratio (UPCR) compared to placebo, achieving the trial’s primary endpoint and generating evidence that povetacicept improves kidney function.
The placebo-adjusted UPCR reduction fell just short of the 50%-plus drop BMO Capital Markets analysts named as the best-case scenario in a note to investors before the readout. Guggenheim Securities said in a note after seeing data that the result is impressive but fairly close to their expectations. Vertex shares rose more than 5% to above $485 in premarket trading Tuesday, March 10.
Citi analysts highlighted secondary endpoint data in a note to investors. With Vertex reporting significant reductions in serum galactose deficient IgA1 and hematuria resolution, Citi analysts said the data show the breadth of povetacicept’s clinical impact. BMO analysts said the candidate was efficacious across subgroups, giving Vertex “an obvious competitive advantage” over Otsuka’s recently approved Voyxact.
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Vertex said povetacicept was generally safe and well tolerated, with no serious adverse events linked to the molecule and no deaths in the trial. BMO analysts received additional details, learning that Vertex reported severe cases of hypogammaglobulinemia. However, while the condition weakens the immune system, severe infection rates on povetacicept were low and comparable to placebo, the analysts said.
Armed with the data, Vertex plans to seek FDA approval by the end of March. Guggenheim analysts said they are impressed by how quickly the biotech aims to complete the submission. The analysts, like their peers at BMO, predicted Vertex could win FDA approval in November. Citi analysts raised their probability of approval to 90% after seeing the phase 3 data.
If approved, povetacicept, which Vertex bought in a $4.9 billion deal in 2024, could compete with drugs including Otsuka’s Voyxact and Vera Therapeutics’ atacicept. Voyxact was the first anti-APRIL drug to win FDA approval in IgAN. The FDA could approve atacicept, a fusion protein that inhibits APRIL and BAFF, by July 7.
Otsuka linked Voyxact to a slightly larger placebo-adjusted UPCR reduction, 51.2%, than povetacicept but a slightly lower UPCR reduction from baseline, 50%. Yet BMO analysts said Voyxact failed to achieve a statistically significant benefit in North American patients, informing their conclusion that povetacicept has best-in-class potential.
