BioCryst Pharmaceuticals has paused further enrollment in the phase 2 REDEEM-1, REDEEM-2, and RENEW clinical trials evaluating BCX9930, an investigational oral Factor D inhibitor, for the treatment of complement-mediated diseases.
The ongoing randomized, double-blind, placebo-controlled REDEEM-1 (ClinicalTrials.gov Identifier: NCT05116774) and REDEEM-2 (ClinicalTrials.gov Identifier: NCT05116787) trials are evaluating the efficacy and safety of BCX9930 in adults with paroxysmal nocturnal hemoglobinuria (PNH). The primary endpoint for both trial is the change from baseline in hemoglobin at week 12.
The ongoing open-label, multicenter, proof-of-concept RENEW trial (ClinicalTrials.gov Identifier: NCT05162066) is evaluating the safety, tolerability, and therapeutic potential of BCX9930 in adults with complement 3 glomerulopathy, immunoglobulin A nephropathy, or primary membranous nephropathy. The primary endpoint is the percentage change from baseline in 24-hour urine protein-to-creatinine ratio at week 24.
The Company has decided to pause enrollment in these clinical trials to investigate elevated serum creatinine levels observed in some patients.
BioCryst pauses enrollment in BCX9930 clinical trials. News release. BioCryst Pharmaceuticals, Inc. Accessed April 8, 2022. https://www.globenewswire.com/news-release/2022/04/08/2419317/29446/en/BioCryst-Pauses-Enrollment-in-BCX9930-Clinical-Trials.html