By Fineline Cube 
France-based major Sanofi (NASDAQ: SNY) has secured Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for riliprubart, an investigational treatment for antibody-mediated rejection (AMR) in organ transplant recipients. This marks a significant step forward in addressing a condition with limited therapeutic options.
Drug Profile
Riliprubart is a potential first-in-class humanized IgG4 monoclonal antibody designed to selectively inhibit activated C1s in the classical complement pathway of the innate immune system. This mechanism of action positions it to address the underlying pathology of AMR, a condition that can lead to transplant organ dysfunction and failure.
Clinical Development
Previously, riliprubart received Orphan Drug Designations from both the FDA and European Commission for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). Building on this momentum, Sanofi is currently conducting a Phase II study to evaluate the safety and efficacy of riliprubart in preventing and treating active AMR in kidney transplant recipients.-Fineline Info & Tech