Dubbed SPRINX-1 Study, the trial aims to assess the safety and efficacy of RXRG001 in treating radiation-induced xerostomia (RIX) [dry mouth] and hyposalivation conditions.
A proprietary product created using circular RNA technology, RXRG001 comprises the circular RNA coding human aquaporin 1 (hAQP1) encapsulated in lipid nanoparticles (LNPs).
It works by restoring water permeability in salivary glands by overexpressing hAQP1, which in turn alleviates the symptoms of dry mouth.
Non-clinical studies in animal models have shown that RXRG001 has a favourable risk and benefit profile. Furthermore, a rise in salivary flow for approximately four weeks was observed following a single administration.
RiboX CEO Dr Weiyi Zhang 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.”
Xerostomia and hyposalivation are side effects of radiation therapy in patients with head and neck cancer (HNC).
Damage to salivary glands from radiation can significantly reduce saliva production, leading to dry mouth, chewing and swallowing difficulties, impaired oral health, and a reduced quality of life.
RiboX chief medical officer Dr Yizhen Xu said: “RIX is a devastating life-long health issue for patients with HNC. Although radiation therapy improves patients’ survival, its damage to the salivary glands leads to an impaired quality of life of many cancer survivors.
“RXRG001 may offer a potential effective and sustained therapeutic option for RIX patients. We are excited to conduct clinical trials to further evaluate its efficacy and safety in patients.”