Mackie Research launched coverage of Aurinia Pharmaceuticals (NASDAQ:AUPH) with a “speculative buy” recommendation and a 12-month target price of $8. The stock closed at $3.03 on Monday.
Aurinia is developing voclosporin as a first-line treatment for lupus nephritis (LN) and advancing the drug candidate into Phase 3 trials.
“Based on the clinical data, market potential of voclosporin, lack of late-stage competitors and the historical track record of management, we believe Aurinia has the potential to be acquired,” writes analyst Andre Uddin.
Aurinia recently announced an interim analysis of its Phase 2b trial, with a low-dose group of voclosporin achieving the primary endpoint, demonstrating statistically significantly greater complete remission than the placebo group. However, the high dose group missed the primary endpoint. The lower dose also hit all secondary endpoints.
In terms of safety, the overall rate of adverse events (AEs) was similar across all three-study groups. The overall rate of serious adverse events (SAEs) was higher in both voclosporin groups but the nature of SAEs is consistent with highly active LN, Mr. Uddin said.
In addition, he said the overall pattern of AEs and SAEs was consistent with that observed in other LN studies. There were 13 deaths across the trial: two in the high-dose voclosporin arm; 10 in the low-dose voclosporin arm; and one in the control arm.
Mr. Uddin also pointed out that the majority of overall deaths (11/13) occurred in developing countries in Asia, where standard of care was compromised to LN patients; all deaths were assessed by the trial investigator as being unrelated to study treatment and no dose relationship was observed for the deaths; and the safety profile of voclosporin demonstrated was in line with other global LN trials.
“In addition, the data safety and monitoring board, which reviews all ongoing clinical data regularly, did not stop the trial due to drug-related deaths,” he added.
