By Siddhi Mahatole and Sriparna Roy
June 4 (Reuters) – Otsuka Pharmaceutical said on Thursday its drug in a late-stage study preserved kidney function over 12 months in patients with a type of autoimmune disease that affects the organ.
Branded as Voyxact, the drug was approved in November to reduce proteinuria in patients with primary immunoglobulin A nephropathy, which causes inflammation in kidneys and can eventually lead to the organ’s failure.
In the study involving 320 participants, those who received the drug showed an increase in kidney function, measured by estimated glomerular filtration rate (eGFR), an indicator of how well the kidneys filter toxins, while patients on placebo saw a decline.
The results indicated a treatment benefit, providing early evidence the drug may help slow the loss in kidney function in patients with IgA nephropathy.
IgAN occurs when a type of antibodies, called immunoglobulin A, build up in the kidneys, causing inflammation while damaging tissues and leaking blood and protein into urine.
The company expects the 24-month data from the late-stage study in two months, John Kraus, chief medical officer told 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 is a monoclonal antibody designed to be administered every four weeks, either through a caregiver or by the patient, providing the option of at-home convenience.
The company has begun a rolling submission to the U.S. Food and Drug Administration seeking traditional approval for the drug based on 24-month data from the same trial.
Other companies, including Vera Therapeutics and Vertex Pharmaceuticals are also developing drugs for IgAN.
(Reporting by Siddhi Mahatole and Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar)
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