Otsuka Pharmaceutical announced Thursday that its medication successfully maintained kidney function during a year-long clinical trial involving patients with an autoimmune condition that targets the kidneys.
The medication, marketed under the name Voyxact, received approval last November for treating proteinuria in individuals diagnosed with primary immunoglobulin A nephropathy, a condition that triggers kidney inflammation and may ultimately result in organ failure.
The clinical trial included 320 participants, with those receiving the treatment demonstrating improved kidney function as measured by estimated glomerular filtration rate (eGFR), which indicates the kidneys’ ability to filter harmful substances. Meanwhile, participants receiving placebo treatment experienced declining function.
These findings suggested therapeutic benefits and offered preliminary evidence that the medication could potentially slow kidney function deterioration in individuals with IgA nephropathy.
IgAN develops when immunoglobulin A antibodies accumulate in the kidneys, triggering inflammation that damages tissue and allows blood and protein to leak into urine.
The pharmaceutical company anticipates receiving 24-month study data within two months, according to chief medical officer John Kraus, who spoke with Reuters.
“This stability of eGFR over that time is incredibly encouraging. And it demonstrates that the reduction we saw in proteinuria did indeed translate to maintaining or preserving the kidney function of those patients that had been randomized to sibeprenlimab,” Kraus said.
Voyxact functions as a monoclonal antibody requiring administration every four weeks, with options for caregiver or patient self-administration, allowing for home-based treatment convenience.
The pharmaceutical company has initiated a rolling submission process with the U.S. Food and Drug Administration to obtain traditional approval for the medication, utilizing 24-month data from the identical trial.
Additional companies, including Vera Therapeutics and Vertex Pharmaceuticals, are currently developing treatments for IgAN.
