Aurinia suspends voclosporin program as Phase 2/3 study fails

• Aurinia Pharmaceuticals (NASDAQ:AUPH) down 10% after-hours after announcing topline data from the Phase 2/3 AUDREY clinical study evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES).
• The trial did not achieve statistical significance on its primary endpoint of a 10mm or greater improvement in Schirmer Tear Test (STT) at four weeks between active dose groups of VOS compared to vehicle.
• A total of 508 subjects were enrolled. The study consisted of four arms with a 1:1:1:1 randomization schedule, in which patients received either 0.2% VOS, 0.1% VOS, 0.05% VOS or vehicle, dosed twice daily for 12 weeks.
• At VOS 0.2%, result was 11%; with Odds-Ratio of 2.48 vs. vehicle (95% CI, p=0.13).
• At VOS 0.1%, result was 9%; with Odds-Ratio of 1.78 (95% CI, p=0.28).
• At VOS 0.05%, result was 10%; with Odds-Ratio of 2.18 (95% CI, p=0.09).
• Aurinia is suspending the development program for VOS based upon these results.
• Secondary outcome measures evaluated in the trial included STT at other time points, Fluorescein Corneal Staining (FCS) at multiple time points, change in eye dryness, burning/stinging, itching, photophobia, eye pain and foreign body sensation at multiple time points, and additional safety endpoints.
• Initial analysis of these secondary outcomes suggests dose-dependent activity and safety were observed across dose groups compared to vehicle.
• https://seekingalpha.com/news/3630145-aurinia-suspends-voclosporin-program-phase-2-3-study-fails-to-achieve-significant-improvement