Trial results show decrease in proteinuria, stabilized GFR with IgA nephropathy drug
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Key takeaways:
- Atacicept showed proteinuria reduction and stabilized eGFR vs. controls in a 36-week trial.
- In up to 50% of cases, IgA nephropathy can lead to kidney failure.
Results from a phase 2 trial of a new drug to treat IgA nephropathy showed a reduction in proteinuria and stabilization of eGFR vs. controls after 36 weeks, according to a presentation at the European Renal Association Congress.
Trial data presented at the conference showed the 150 mg dose of atacicept (Vera Therapeutics) was also well tolerated with a safety profile similar to placebo.
“The phase 2b trial met its primary endpoint of significant proteinuria reduction at week 24 in [IgA nephropathy] IgAN patients at high risk of disease progression,” Richard Lafayette, MD, FACP, professor of medicine in nephrology and director of the Stanford Glomerular Disease Center at Stanford University Medical Center, said during the late-breaking session. “At week 36, patients receiving atacicept 150 mg had a statistically significant 43% reduction in proteinuria compared to placebo. Patients receiving atacicept had stable eGFR through week 36, demonstrating a statistically significant and clinically meaningful difference of 5.8 mL/min/1.73 m2 compared to placebo at week 36,” he said.
“In the [intention-to-treat] analysis of all randomized patients, patients receiving placebo had an expected decline in kidney function as measured by eGFR ... This difference in eGFR was statistically significant (delta 11%, P = .038) and clinically significant (5.8 mL/min/1.73 m 2),” according to a press release from Vera Therapeutics Inc.
Fusion protein
ORIGIN is a multinational, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of atacicept, a fusion protein self-administered as a subcutaneous injection once weekly intended to block a B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL) that stimulate B cells and plasma cells to produce autoantibodies. The autoantibodies contribute to certain autoimmune diseases, including IgAN, according to the release.
“The week 36 results of the phase 2b ORIGIN clinical trial build on a growing body of data that demonstrates atacicept's potential to modify and delay disease progression in IgAN,” Lafayette said in the release. “We believe this is best characterized by the early signs of eGFR stabilization and a significant 43% reduction in proteinuria for the atacicept 150 mg group compared to placebo.
“These data also demonstrate the therapeutic potential of the BLyS and APRIL dual inhibitor approach to treating the root cause of IgAN,” Lafayette said.
Most common
IgAN is a progressive autoimmune disease that triggers autoantibodies, leading to the formation of pathogenic immune complexes in kidney glomeruli that causes inflammation and progressive damage.
In an interview with Healio | Nephrology News and Issues, Lafayette said IgAN is the most common autoimmune disease. “It is the most common primary glomerular disease throughout the world,” he said. “It affects the Asian population a little more than white individuals, and it affects white individuals more than Black individuals,” Lafayette said. “It is responsible for getting around 5,000 Americans sick every year, and probably the fourth or fifth cause of patients ending up on dialysis.”
Most patients do not have symptoms and present late with proteinuria, Lafayette said. “It’s a serious disease and needs attention,” he said.
Follow-up evaluating the efficacy of the drug will continue at 48 and 96 weeks in the phase 2b study group, Lafayette said. Vera is recruiting patients for phase 3 of ORIGIN and will have a 4-week screening period, a 104-week double-blind treatment period, a 52-week open-label extension for the trial and 26 weeks of follow-up with similar endpoints, the company said.
Reference:
Lafayette R, et al. 36-week efficacy & safety of atacicept 150 mg in the ORIGIN randomized, double-blind, placebo-controlled phase 2b study in IgAN and persistent proteinuria. Presented at: European Renal Association Congress; June 15-18, 2023; Milan (hybrid meeting). https://ir.veratx.com/static-files/d50cc62b-1cfe-47db-b70c-5787206a0153.
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