Be Biopharma Announces FDA Clearance of IND Application for BE-101 in Hemophilia B
Be Biopharma, Inc. (“Be Bio”), a company pioneering the discovery and development of Engineered B Cell Medicines (BCMs), today announced the clearance of its Investigational New Drug application (IND) from the U.S. Food and Drug Administration (FDA) for BE-101, a first-in-class BCM in development for the potential treatment of hemophilia B.
- Be Biopharma, Inc. (“Be Bio”), a company pioneering the discovery and development of Engineered B Cell Medicines (BCMs), today announced the clearance of its Investigational New Drug application (IND) from the U.S. Food and Drug Administration (FDA) for BE-101, a first-in-class BCM in development for the potential treatment of hemophilia B.
- The Phase 1/2 clinical trial, BeCoMe-9, is a multi-center, first-in-human dose escalation study designed to assess the safety and preliminary efficacy of BE-101 in adult participants with moderately severe to severe hemophilia B.
- Adults and children with hemophilia B have long sought a single dose Factor IX replacement therapy with extreme durability while retaining the dosing flexibility of the current standard of care.
- Additionally, the redosability of BE-101 has been demonstrated, resulting in a predictable increase in plasma FIX levels.