Otsuka Pharmaceutical’s 2018 purchase of Visterra seems to be paying off after its anti-APRIL antibody passed a registrational test in a rare kidney disease.
The IgA nephropathy (IgAN) antibody, named sibeprenlimab, hit the trial’s primary endpoint by achieving a “statistically significant and clinically meaningful” reduction in 24-hour urine protein-to-creatine ratio versus placebo at nine months, according to a Tuesday release. The study enrolled 530 people with IgAN who were taking standard of care.
Otsuka said it plans to review the interim data with the FDA with an eye to accelerated approval. Bank of America Securities analysts said sibeprenlimab could become a first-in-class biologic for IgAN with approval possible as soon as the second half of next year.
The Phase 3 trial is ongoing and expected to end in 2026. The company is tracking the study’s secondary endpoints like change in kidney function over 24 months.
The Japanese company added sibeprenlimab to its pipeline as part of its $430 million buyout of Visterra in 2018. The monoclonal antibody works by blocking APRIL, a cytokine that plays a key role in B cell dysregulation and the overproduction of galactose-deficient IgA1.
The APRIL target has been at the heart of several major deals, including Vertex’s $4.9 billion acquisition of Alpine Immune Sciences and its dual BAFF/APRIL antagonist povetacicept, which is set to enter Phase 3 development this year. Last year, Novartis spent $3.2 billion on Chinook Therapeutics and its pipeline of kidney drugs, including anti-APRIL antibody zigakibart.
Otsuka has projected its drug could reach more than 100 billion Japanese Yen ($663 million) in peak sales. The BofA analysts’ expectations were even higher at around 505 billion Japanese Yen ($3.3 billion) in 2035.
Jefferies analysts said cross-trial comparisons suggest sibeprenlimab has best-in-class potential, as well as more convenient dosing. IgAN affects around 390,000 people in the US, EU and Japan, the analysts added. It is the leading cause of kidney disease in young people.