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An experimental medicine Otsuka Pharmaceutical acquired in a buyout six years ago has succeeded in a Phase 3 trial in a rare kidney disease, the company said Tuesday.
The drug, called sibeprenlimab, met its main goal in a study in IgA nephropathy, or IgAN, a chronic condition that can lead to kidney failure. Upon a pre-specified, interim analysis after nine months of treatment, the company said sibeprenlimab therapy was associated with a “statistically significant and clinically meaningful” reduction, versus placebo, in the amount of protein in participants’ urine — a marker of kidney health.
Otsuka didn’t provide specifics, making the magnitude of the drug’s effects unclear. It also said, without details, that the drug’s safety profile was “consistent with previously reported data.” But the company intends to discuss with the Food and Drug Administration the possibility of an accelerated approval filing while the study continues. The trial is expected to wrap up in early 2026.
For Otsuka, the results are a measure of validation for its bet on Visterra, a Waltham, Massachusetts-based biotechnology startup and sibeprenlimab’s developer. Visterra was founded in 2008 around a type of antibody drug discovery technology that originated at MIT. The company initially used that technology to develop drugs for infectious diseases before broadening its therapeutic scope, and tried, unsuccessfully, to go public in 2017.
Otsuka stepped in a year later and acquired the company for $430 million in upfront cash. Visterra has since operated as a wholly owned subsidiary of Otsuka and has still been run by its longtime CEO, Brian Pereira. The company now has a pipeline of drugs mostly for immune diseases and led by sibeprenlimab, which, following Tuesday’s study results, could become the first treatment of its kind for IgAN.
Some estimates hold that upwards of 130,000 people in the U.S. have IgAN, a progressive autoimmune condition that damages the kidneys. While several therapies are available, there remains room for improvement, as patients with the disease still see their kidney function decline.
The need for better therapies, along with a growing understanding of the disease’s underlying biology, has made IgAN a focus of an increasing number of drug companies. Since 2023, Novartis, Biogen and Vertex Pharmaceuticals have all acquired biotechs with IgAN drugs in testing. Travere Therapeutics and Calliditas Therapeutics have recently launched IgAN medicines. Others, including Q32 Bio and Vera Therapeutics, are advancing would-be therapies as well.