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Shares in Aurinia Pharmaceuticals (AUPH) tanked 10% after-hours after the biopharma announced disappointing 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 the Schirmer Tear Test (STT) at four weeks between active dose groups of VOS compared to vehicle.
As a result, Aurinia is now suspending the development program for VOS.
“While surprised by these results, we remain focused on preparing voclosporin for lupus nephritis – which has a different formulation and delivery mechanism compared to VOS. As we approach our lupus nephritis PDUFA action date, the Aurinia team remains committed to our mission of developing novel treatments for people with debilitating and severe autoimmune disease” commented CEO Peter Greenleaf.
The trial was a randomized, double-masked, vehicle-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of 508 subjects were enrolled.
As well as the primary endpoint, 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.
According to Aurinia, initial analysis of these secondary outcomes suggests dose-dependent activity and safety were observed across dose groups compared to vehicle. Further analysis will be conducted over the coming weeks, the company says. (See AUPH stock analysis on TipRanks).
On a year-to-date basis, the stock is now trading down 23% yet the Street has a bullish Strong Buy consensus on Aurinia. That’s with 4 recent buy ratings. The average analyst price target indicates upside potential of over 60% lies ahead.
Oppenheimer’s Justin Kim remains enthusiastic about the company’s prospects in lupus nephritis (LN). He reiterated his buy rating on AUPH with a $20 price target on November 2. Kim cites Aurinia’s “thoughtful and committed approach to launching this potential therapeutic in the LN space, supported by the drug’s highly differentiated product profile.”
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