RiboX Therapeutics Receives FDA IND Clearance for Autoimmune Cytopenia Therapy
RiboX Therapeutics has received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for RXIM002, enabling a Phase 1 clinical trial.
RiboX Therapeutics announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for RXIM002. This clearance allows the company to proceed with initiating a Phase 1 clinical trial.
The trial will evaluate a targeted, lipid nanoparticle-delivered, in vivo CAR-T therapy for autoimmune cytopenias. Autoimmune cytopenias occur when the immune system mistakenly attacks the body's own blood cells.
RXIM002 utilizes circular RNA (circRNA) technology for its in vivo gene therapy approach. This method differs from traditional RNA therapies and aims to enhance treatment efficacy and safety through precise targeting.
The primary objective of the Phase 1 study is to assess the safety and tolerability of RXIM002 in patients diagnosed with autoimmune cytopenias. The findings from this initial study will inform the future development path for the therapy.