Vera Therapeutics has concluded subject enrolment in the Phase IIb ORIGIN clinical trial of atacicept in IgA nephropathy (IgAN) patients.
An investigational recombinant fusion protein, atacicept is a disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL).
The multinational, randomised, double-blind, placebo-controlled, multicentre, dose-ranging trial is assessing atacicept’s safety and efficacy in 115 IgAN patients.
It will include IgAN patients who have persistent proteinuria and are at increased disease progression risk despite being on a stable prescribed regimen of renin-angiotensin-aldosterone system inhibition (RAASi) with an angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB).
Subjects were randomised into a 2:2:1:2 ratio to receive 25mg, 75mg, 150mg atacicept or placebo every week by prefilled syringe.
On concluding the 36-week blinded treatment period, all participants will be given an open-label 150mg dose of atacicept for another 60 weeks.
Assessing the impact of atacicept on proteinuria and preservation of renal function versus placebo to identify the appropriate dose(s) for future clinical trials are the trial’s goals.
The variation in proteinuria as analysed by urine protein to creatinine ratio (UPCR) UPCR at week 24 and 36, respectively, are the primary and secondary endpoints of the trial.
This variation as assessed by UPCR at 12, 48, and 96 weeks, variation in levels of serum immunoglobulin and serum Gd-IgA1, rate of change in estimated glomerular filtration rate (eGFR), safety, tolerability and serum pharmacokinetics (PK) were included as the trial’s other secondary endpoints.
Vera Therapeutics chief medical officer Celia Lin said: “We are excited to complete enrollment in the Phase IIb ORIGIN trial and reach this significant milestone for atacicept as we work diligently amidst a global pandemic and geopolitical crises to provide a much-needed treatment option for patients with IgAN.
“We believe atacicept could have a profound benefit for patients with IgAN and look forward to topline results of this study expected to be announced later this year.”