Benzinga -
- Vera Therapeutics Inc (NASDAQ: VERA) unveiled topline data from Phase 2b ORIGIN trial of atacicept in patients with immunoglobulin A nephropathy (IgAN).
- The trial evaluated three doses of atacicept - 150 mg, 75 mg, and 25 mg, versus the placebo.
- A pooled group of IgAN patients receiving either a 75 mg or 150 mg dose of atacicept saw a 31% mean reduction from baseline in proteinuria, protein levels in the urine, compared to 7% in the placebo group at 24 weeks, meeting the primary endpoint.
- While the 25 mg and 75 mg dose groups failed to meet statistical significance, the 150 mg group showed a 33% reduction.
- The company says a trend towards further reductions in proteinuria was observed in the all-atacicept group versus placebo, with 38% of patient data available at Week 36.
- Atacicept was generally well-tolerated, with serious treatment-emergent adverse events occurring in 2% of atacicept patients and 9% of patients in the placebo arm.
- Vera plans to advance atacicept into pivotal Phase 3 development in the first half of 2023.
- Upon completing the 36-week blinded treatment period, all patients are offered open-label atacicept 150 mg for an additional 60 weeks.
- After the above data, the company plans to take the 150 mg dose forward into planned Phase 3 pivotal trial.
- Price Action: VERA shares are down 62.95% at $6.78 during the premarket session on the last check Wednesday.