News

The first subject has been enrolled and administrated with SR604 in United States in the Phase 1 study of SR604 (NCT06349473), a clinical trial being conducted following approvals of the Investigational New Drug (IND) Application by the U.S. FDA. The clinical trial program started with enrollment of healthy participants and will expand to participants with Hemophilia A or Hemophilia B, with or without inhibitors.
The single ascending dose portion of the Phase 1 clinical study (Part A) is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SR604 in healthy participants. The multiple ascending dose portion of the Phase 1 clinical study (Part B) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SR604 in participants with Hemophilia A or Hemophilia B.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to SR604, an investigational new drug of monoclonal antibody against activated protein C (APC), for the routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with severe hemophilia A and severe hemophilia B with or without inhibitors.

The U.S. FDA has cleared the company’s Investigational New Drug (IND) Application for SR604. SR604 is a potent monoclonal antibody specific to activated protein C (APC) that selectively blocks the anticoagulant activity of human APC while maintaining cytoprotective and anti-inflammatory functions. The proposed indication for SR604 is routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with severe hemophilia A and severe hemophilia B with or without inhibitors.

Equilibra Bioscience Received FDA Orphan Drug Designation (ODD) for recombinant anti-human activated protein C humanized monoclonal antibody (SR604) for the treatment of Hemophilia A and Hemophilia B.