- BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) has paused enrollment in clinical trials with BCX9930 as the Company investigates elevated serum creatinine levels seen in some patients.
- The Company will not enroll new patients in the REDEEM-1, REDEEM-2, or RENEW clinical trials during the investigation.
- Patients currently enrolled in the trials are continuing on the study drug.
- REDEEM-1 and REDEEM-2 are evaluating the Company's oral Factor D inhibitor, BCX9930 (500 mg bid), in patients with paroxysmal nocturnal hemoglobinuria (PNH). This disorder leads to premature death and impaired production of blood cells.
- REDEEM-1 is a randomized, open-label, active, comparator-controlled comparison of the efficacy and safety of BCX9930 monotherapy in approximately 81 PNH patients with an inadequate response to a C5 inhibitor.
- Related: BioCryst Shares Gain As Royalty Pharma Buys Additional Interests In BCX9930, Orladeyo.
- REDEEM-2 is a randomized, placebo-controlled trial to evaluate the efficacy and safety of BCX9930 as monotherapy versus placebo in approximately 57 PNH patients not currently receiving complement inhibitor therapy.
- The Company also has begun patient enrollment for RENEW, a proof-of-concept basket trial of oral BCX9930 (500 mg bid) in complement-mediated renal diseases.
- Price Action: BCRX shares are down 33.30% at $11.93 during the market session on the last check Friday.
