Benzinga | Jul 15, 2021 09:42AM EDT

BioCryst Outlines Pivotal Trial Designs For BCX9930 In Rare Blood Disorder

* BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) has announced the designs for REDEEM-1 and REDEEM-2, two upcoming pivotal trials for its oral Factor D inhibitor, BCX9930, in patients with paroxysmal nocturnal hemoglobinuria (PNH).

* REDEEM-1 will compare the efficacy and safety of BCX9930 monotherapy versus C5 inhibitor in approximately 81 PNH patients.

* REDEEM-2 will evaluate the efficacy and safety of BCX9930 as monotherapy versus placebo in approximately 57 PNH patients not currently receiving complement inhibitor therapy.

* The primary endpoint for both trials is the change from baseline in hemoglobin (Hb), assessed at weeks 12 to 24 in REDEEM-1 and at week 12 in REDEEM-2.

* Key secondary endpoints for both trials are the proportion of transfusion-free subjects, the number of units of packed red blood cells (pRBC) transfused, and change from baseline in FACIT-Fatigue score.

* Enrollment will start in the second half of 2021.

* Price Action: BCRX shares are down 0.32% at $15.58 during the market session on the last check Thursday.