Putting the safe­ty is­sue to bed, Au­rini­a's late-stage lu­pus nephri­tis da­ta shines

Af­ter a check­ered mid-stage pro­gram marred by pa­tient deaths, Au­rinia emerged vic­to­ri­ous on Wednes­day with Phase III lu­pus nephri­tis da­ta that demon­strat­ed its lead drug is safe and ef­fec­tive for a pa­tient pop­u­la­tion that has few op­tions.

Au­rinia’s shares sky­rock­et­ed in Thurs­day morn­ing pre­mar­ket trad­ing, as the Cana­di­an biotech un­veiled plans to sub­mit a mar­ket­ing ap­pli­ca­tion next year.

The 357-pa­tient place­bo-con­trolled AU­RO­RA tri­al test­ed the com­pa­ny’s drug, vo­closporin, in com­bi­na­tion with my­cophe­no­late and low-dose cor­ti­cos­teroids to eval­u­ate whether the ther­a­py could im­prove the speed of and over­all re­nal re­sponse rates in pa­tients with lu­pus nephri­tis, where the au­toim­mune dis­ease rav­ages the kid­neys, trig­ger­ing in­flam­ma­tion that could lead to blood and/or pro­tein in the urine, high blood pres­sure, poor kid­ney func­tion, or kid­ney fail­ure.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER