The Phase III results impressed Guggenheim Partners analysts both in terms of efficacy and safety. If approved, atacicept would become the first APRIL/BAFF inhibitor for IgAN to make it to the market.
Vera Therapeutics is planning an FDA submission for its drug atacicept by the end of the year after it significantly lowered urinary protein levels in a Phase III study of IgA nephropathy.
In the late-stage ORIGIN study, atacicept treatment led to a 46% reduction in proteinuria at 36 weeks versus baseline. When compared to placebo, atacicept’s benefit remained high at 42%. The trial also cleared its secondary endpoints, a 68% drop in a disease biomarker and cessation of blood in urine in 81% of patients.
Reacting to these data, analysts at Guggenheim Partners on Thursday said that Vera has established a “compelling profile” for atacicept, bolstered by “an excellent safety profile that is comparable to placebo.” Findings from ORIGIN pointed to fewer serious adverse events in atacicept-treated patients versus placebo, with no safety signals that could indicate immunosuppression.
The ORIGIN readout “reinforces atacicpet’s potential as a first-line disease-modifying therapy,” Guggenheim said, “and validates our view that long-term eGFR preservation will be a key differentiator in the increasingly competitive IgAN landscape.” ORIGIN is ongoing and is scheduled to complete in 2028.
Vera is planning to file a biologics license application (BLA) for atacicept in IgAN in the fourth quarter, which according to Guggenheim could mean a product launch in mid-2026.
Such a timeline, the analysts said, would place Vera and atacicept “approximately 6–9 months behind Otsuka’s sibeprenlimab,” which has an FDA decision date of Nov. 28. Phase III data released in June showed that sibeprenlimab decreased proteinuria by 51.2% versus placebo, which at the time Guggenheim said “represents the strongest numerical result reported to date in IgAN Phase 3 trials.”
Nevertheless, an approval by mid-2026 would put Vera “ahead” of other firms developing similar therapies, according to Guggenheim. One such competitor Vertex Pharmaceuticals, whose povetacicept is also in line for a potential approval next year. Analysts and investors appear optimistic about that drug’s prospects. In a Nov. 3 note to investors, BMO Capital Markets said that povetacicept is set to “become a focal point” for Vertex’s pipeline.
Vertex has fully enrolled its Phase III RAINIER study for povetacicept and expects to complete its rolling application in the first half of 2026.
If atacicept is approved, Vera will beat Vertex to the market by a few months. “We believe that atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor,” Vera CEO Marshall Fordyce said in a statement on Thursday.
