Biopharmaceutical company RiboX Therapeutics Ltd. announced on Friday that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application for the Phase I/IIa Study of RXRG001 (SPRINX-1 Study).

The first-in-human SPRINX-1 study is designed to evaluate the safety and efficacy of RXRG001 in patients with radiation-induced-xerostomia (RIX) (dry mouth) and hyposalivation (low saliva secretion).

RXRG001 is claimed to be the first-ever circular RNA therapy to receive FDA IND clearance. The company says that this important advancement marks a significant milestone as circular RNA drugs advance into the clinical development phase. RXRG001 consists of the circular RNA coding human aquaporin 1 (hAQP1, a water channel protein of cell membrane), encapsulated in lipid nanoparticles (LNPs).

Dr Weiyi Zhang, RiboX chief executive officer, said, 'The FDA's clearance of the IND application for RXRG001 is an acknowledgment of our innovative capabilities, robust technology, and competitiveness in the field of circular RNA therapeutics. RiboX will advance the clinical development of RXRG001, continue leveraging the unique advantages of circular RNA technology in therapeutic applications, and introduce more pioneering treatments to patients around the world.'