Arde­lyx's lead drug tena­panor scores in sec­ond hy­per­phos­phatemia study, shares leap

As the FDA’s de­ci­sion date on Arde­lyx’s lead drug, tena­panor, for use in ir­ri­ta­ble bow­el syn­drome looms — the Cal­i­for­nia drug de­vel­op­er un­veiled pos­i­tive da­ta from a late-stage study test­ing the small mol­e­cule in pa­tients with chron­ic kid­ney dis­ease (CKD).

The drug, which is en­gi­neered to tar­get NHE3 trans­porter in the gut to pro­mote tight­en­ing of ep­ithe­lial cell junc­tions and ex­cre­tion of ex­cess phos­phate, was test­ed in com­bi­na­tion in CKD pa­tients on dial­y­sis whose hy­per­phos­phatemia is not un­der con­trol with binders alone.

The tri­al, called AM­PLI­FY, en­rolled 236 pa­tients with CKD on dial­y­sis, who had el­e­vat­ed phos­phate lev­els de­spite a binder reg­i­men. Base­line serum phos­pho­rus at ran­dom­iza­tion was at a mean lev­el of 6.8 mg/dL.

The re­sults were pos­i­tive all around: The drug met the main goal, as well as all the sec­ondary end­points. The com­pa­ny’s shares $ARDX jumped about 28% to $4.35 be­fore the bell on Tues­day.

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