Extended Half-Life of the Double-Chain Recombinant Factor VIII-Fc Fusion Protein (FRSW107) in Hemophilia a Patients

• Published in: Blood Vol. 134; no. Supplement_1; p. 4932
• Main Authors: Xue, Feng, Sun, Jing, Chen, Yun, Zhang, Xinsheng, Sun, Haiyan, Wang, Yali, Yang, Renchi
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 13.11.2019
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2019-128600

Objective:To determine pharmacokinetics (PK), safety and tolerability of a double-chain recombinant human factor VIII-Fc fusion protein (FRSW107) in previously treated patients (PTPs) in clinical trial which was registered at www.clinicaltrials.gov as NCT03747653 and scheduled to finish at end of July, 2019. Methods:At least 12 PTPs (12 to 60 years old) with FVIII:C<2% and without history of FVIII inhibitors received a single dose of rFVIII (Advate) at 25 or 65 IU/kg followed by an equal dose of FRSW107. Results: Up-on the data from 7 subjects received 25 IU/kg , the geometric mean t1/2 of FRSW107 was 26.23 hours. This represents a 1.98-fold improvement over that of rFVIII (13.34 hours) at equivalent doses. All adverse events were unrelated to study drug. None of the study subjects developed FVIII inhibitors. Conclusion:According to the preliminary data from this phase 1 clinical trial, FRSW107 shows a significantly extended half- life compared to control FVIII while no safety issue identified. No relevant conflicts of interest to declare.