Aurinia Pharmaceuticals saw its shares plunge on Monday after releasing data related to its lupus therapy, voclosporin.
Initial information seemed strong for the company. Results from a Phase 2b study focusing on 265 patients with active lupus nephritis had shown the drug was able to demonstrate “statistically significant greater complete remission” of lupus, reported FierceBiotech, although there were 13 deaths recorded in the study.
Active lupus nephritis is a variant of the autoimmune disease that can cause complications in the kidney. Scientists running this investigation treated patients with two doses of voclosporin each day over the course of 24 weeks. An estimated 32.6 percent of patients in the low-dose arm of the study experienced complete remission compared to 27.3 percent in the high-dose arm and 19.3 percent in the control arm who had undergone remission.
However, analysts questioned how those taking the low dose could get higher complete remission rates than the high-dose section of the experiment.
Executives from Aurinia said that 40 percent of the enrolled patients in this study were based in Asia where most of these deaths happened, wrote Endpoint News. The company contended these deaths had no link to the drug itself and could be attributed to the treatment standards used overseas in Asia.
Joseph Schwartz, an analyst for financial services firm Leerink, told Endpoints that these deaths indicated that voclosporin needs to be studied further, along with the positive study results.
Aurinia plans on meeting with the Food and Drug Administration at the end of the year to discuss progressing voclosporin’s clinical development.
The company’s shares plummeted over 55 percent on Monday.
Filed Under: Drug Discovery