FDA grants RMAT designation to RiboX’s RXRG001 for xerostomia

The FDA has granted RMAT designation to RiboX Therapeutics’ investigational treatment RXRG001 for RIX and hyposalivation. The designation was based on preliminary clinical evidence from the ongoing SPRINX-1 Phase I/IIa study. RXRG001 is a proprietary circular RNA therapy encoding human aquaporin-1, a protein involved in fluid transport. Credit: Krisana Antharith / Shutterstock.com. The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to RiboX Therapeutics’ investigational treatment RXRG001 for radiation-induced xerostomia (RIX) and hyposalivation. RXRG001 is a circular ribonucleic acid (RNA) therapy encoding human aquaporin-1, a protein involved in fluid transport. LOA and PTSR Model…

Source: Pharmaceutical Technology