RiboX Therapeutics, a Shanghai-based developer of circular RNA (circRNA) therapies, has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate the Phase I/IIa clinical study SPRINX-1 for its candidate RXRG001. This study will evaluate the efficacy and safety of RXRG001 in patients suffering from radiation-induced xerostomia (RIX), commonly known as dry mouth, and hyposalivation, which is characterized by low saliva secretion.
Radiation therapy, a primary treatment modality for head and neck cancer (HNC), often leads to damage of the salivary glands and a significant reduction in saliva production. This can result in dry mouth, difficulties in chewing and swallowing, impaired oral health, and a reduced quality of life. Currently, there is no effective treatment for RIX available in clinics globally.
RXRG001, a proprietary product utilizing innovative circular RNA technology, aims to increase saliva production by restoring water permeability through the overexpression of the hAQP1 gene, thereby alleviating dry mouth symptoms. Non-clinical studies have shown a favorable risk-benefit profile for RXRG001 in animal models, with a single administration leading to a significant and sustained increase in salivary flow for approximately four weeks. The clinical approval marks RXRG001 as the first-ever circular RNA therapy to receive FDA IND clearance and the world’s first of its kind to enter clinical trials for the treatment of RIX.- Flcube.com
