Vera Therapeutics Eyes Phase 3 For Kidney Disease Candidate Following Positive Data

California-based Vera Therapeutics has announced positive Phase 2b results for atacicept, a candidate for immunoglobulin A nephropathy (IgAN), an autoimmune kidney disease. 

If the discussion with the US FDA goes well, atacicept is expected to begin pivotal Phase 3 development for the drug in the first half of 2023.

Atacicept was out-licensed from Merck (known as MSD outside the US and Canada) in November 2020. The agreement saw Merck take up a 10% equity stake in Vera as well as promises of up to € 605 million ($642 million) in milestone payments and royalties on any potential sales. 

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Atacicept Reduced Mean Proteinuria 

Atacicept is designed to inhibit B-cells and plasma cells that produce autoantibodies in autoimmune diseases like IgA nephropathy and lupus nephritis.

A recombinational fusion protein, atacicept contains a transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to two cytokines, the B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). 

The Phase 2b trial, a.k.a. Origin enrolled 116 IgAN patients to evaluate the efficacy and safety of atacicept. The patients had presented persistent proteinuria (protein in the urine) and were at high risk of disease progression despite ACE and ARB therapy. 

Atacicept met the trial’s primary endpoint at week 24, showing a mean proteinuria reduction of 31% in the 75 mg dose group and a 33% mean reduction at 150 mg. 

The drug also significantly reduced galactose-deficient IgA1 (Gd-IgA1) from baseline through 24 weeks. Overproduction of Gd-IgA1 is a driver of IgAN, as it triggers autoantibody production that leads to disease-causing complexes in the kidney’s glomeruli. 

The safety results of atacicept in Origin were consistent with those of previous studies, indicating that the candidate is well-tolerated. Adverse events led to a discontinuation rate of 1%. Serious side effects were observed in 2% of patients in the atacicept arm and 9% in the placebo arm. 

Vera CEO Marshall Fordyce, MD, has heralded the positive results of atacicept as an important milestone for both the company and the IgAN community. 

“Atacicept could be a transformational treatment for patients with IgAN who currently have limited treatment options. We look forward to rapidly advancing the 150 mg dose into our planned Phase 3 pivotal trial,” said Fordyce in a statement. 

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Joy Lin

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