The phase 1 trial of the voclosporin, a drug developed by Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) for the treatment of lupus nephritis, has returned encouraging results. The trial was conducted on Japanese patients and the results were consistent with what had been observed in patients of non-Japanese heritage. Patients involved in the trial did not report any unexpected or strange events with regards to safety.
“We are encouraged by these results … the data support the use of the 23.7mg BID voclosporin dose in our global Phase 3 study in both Japanese and non-Japanese patients,” Lawrence Mandt, a Regulatory and Quality Control vice president at Aurinia said.
Kidney inflammation
With lupus nephritis, the most common characteristic is that the kidney of a patient suffering from the condition gets highly inflamed to the extent that the condition can turn out to be disabling. Currently, there are more than half a million people in the United States who suffer from the condition. A majority of these patients are women.
The cost of treating lupus nephritis can be very high if the management of the disease is poor. In such a case, serious consequences such as permanent damage to the kidney can result. This can, in turn, lead to a fatal and serious renal disease.
Regulator approval
Following the encouraging results of the trial, Aurinia is now planning to present the findings to PMDA – Pharmaceuticals, and Medical Devices Agency. The firm will also embark on getting the drug approved by the Japanese regulator.
The development comes in the wake of executive and board changes at Aurinia Pharmaceuticals. Charles Rowland has left as the chief executive officer and has been replaced by Richard Glickman who was the board’s chairman. Besides serving as the new CEO, Glickman will continue to chair the board. As a co-founder of Aspreva Pharmaceuticals which went on to be acquired in 2008 for $1 billion, Glickman’s experience in the pharmaceutical sector has been long and rewarding. Glickman also serves on the boards of other pharmaceutical or pharmaceutical-related firms.
On Friday shares of Aurinia Pharmaceuticals Inc jumped sharply by 13.41% to close the day at $3.72.
