(Reuters) - Aurinia Pharmaceuticals Inc said there were no further deaths in patients given its experimental lupus drug in a mid-stage study, allaying safety concerns as the drug developer prepares to start a pivotal study later this year.
Two doses of the drug, voclosporin, were being tested against a placebo in a 48-week study in patients with lupus nephritis (LN) who were already on the standard-of-care therapy.
In August, the company had disclosed 13 trial deaths — 12 of which occurred in voclosporin-treated patients — after 24 weeks.
On Wednesday, the company reported full 48-week data, and said there were three more deaths, but all occurred in the placebo arm.
LN is a life-threatening condition that develops in up to 60 percent of patients with lupus, a disorder in which the body’s immune system attacks itself.
Patients’ kidneys become inflamed and leak protein, causing tissue damage and even renal failure. Existing treatments, typically steroids, are riddled with side effects often making them difficult for patients to endure.
In August, Aurinia said voclosporin had met the main goal of improving remission rates at 24 weeks, but its shares fell sharply after the company disclosed 13 deaths in the trial, which it said were unrelated to the drug.
The data also demonstrated a higher overall rate of serious side effects in patients on voclosporin.
When the 24-week data was released, investors overreacted to the study deaths, failing to take into account that the mortality rate was similar to other recent LN trials, Leerink’s Joseph Schwartz wrote in a note in February.
On Wednesday, the Canadian company said there were no unexpected side effects or additional deaths in voclosporin-treated patients at 48 weeks.
However, there were three deaths and one malignancy reported in patients given the placebo, Aurinia added.
In terms of efficacy, both doses of the drug continued to improve remission rates at 48 weeks. Twice as many patients given the lower voclosporin dose induced a complete renal response versus placebo, data showed.
A late-stage LN study testing voclosporin, which has been granted the U.S. Food and Drug Administration’s fast track status, is slated to begin later this year.
More than 500,000 people in the United States, mostly women, suffer from lupus, including pop singer Selena Gomez.
GlaxoSmithKline Plc won U.S. approval for its lupus drug, Benlysta, in 2011. It was then, the first drug approval for the condition in over fifty years. (bit.ly/2mLG1Vv)
Reporting by Natalie Grover in Bengaluru; Editing by Shounak Dasgupta