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Vera Therapeutics Announces Phase 3 Clinical Trial for Atacicept in Lupus Nephritis
- Positive feedback from FDA to initiate Phase 3 trial of atacicept in patients with LN - BRISBANE, Calif., Jan. 18, 2022 (GLOBE NEWSWIRE) -- Vera
About this update from Vera Therapeutics, Inc.
[{"type":"text","content":"- Positive feedback from FDA to initiate Phase 3 trial of atacicept in patients with LN -\nBRISBANE, Calif., Jan. 18, 2022 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, announced plans to initiate a Phase 3 clinical trial of its lead product candidate atacicept in lupus nephritis (LN). This announcement comes after positive feedback from the U.S. Food and Drug Administration (FDA)’s review of the proposed Phase 3 trial. Lupus nephritis, a severe renal manifestation of systemic lupus erythematosus (SLE), causes kidney inflammation, which leads to blood and protein in the urine, high blood pressure, impaired kidney function, and eventually approximately 25 percent of LN patients develop end stage renal disease. “Fewer than half of patients treated for LN have a complete response to current therapies, and among patients without a complete response, more than half will have non-functioning kidneys within five years,” said Vera founder and CEO Marshall Fordyce, MD. “Atacicept has the potential to offer a significant improvement over standard of care for patients who currently have limited options. Atacicept has been administered to more than 1,400 patients in clinical studies across different indications. We look forward to initiating this Phase 3 trial and working with the FDA and other regulators to evolve the standard of care for LN patients.” The Phase 3 randomized, double-blinded, placebo-controlled trial will evaluate the efficacy and safety of atacicept in subjects with LN by assessing 150 milligrams of once-weekly subcutaneous injections of atacicept versus placebo. The clinical trial consists of a 52-week double-blind treatment period, followed by a 104-week open-label treatment period and a 26-week safety follow-up period. The primary endpoint for the trial is complete renal response at 52 weeks. Additional Clinical TrialsAtacicept is also currently being evaluated for the treatment of immunoglobulin A nephropathy (IgAN) in the Phase 2b ORIGIN trial, which Vera expects will complete enrollment in mid-2022. If the data from this trial are positive, Vera plans to seek an accelerated approval path from the FDA and European Medicines Agency (EMA) for IgAN while in...