RiboX Therapeutics Announces First Patient Dosed in Phase I/IIa Clinical Trial of RXRG001, the First Circular RNA Therapy for the Treatment of Radiation-Induced Xerostomia and Hyposalivation

PRINCETON, N.J., March 10, 2025 /PRNewswire/ -- RiboX Therapeutics Ltd. (RiboX), a pioneering biopharmaceutical company, focused on discovering and developing fully engineered circular RNA therapeutics, today announced that the first patient was dosed last week in its first-in-human (FIH) Phase I/IIa clinical trial (SPRINX-1) evaluating the safety and efficacy of RXRG001 in patients with radiation-induced-xerostomia (RIX) and hyposalivation.

Xerostomia and hyposalivation are common side effects of radiation therapy in head and neck cancer (HNC) patients. Radiation therapy often results in damage to salivary glands and a significant decrease in saliva secretion, frequently leading to dry mouth, difficulties in chewing and swallowing, impaired oral health, and diminished quality of life. There is a significant unmet medical need to develop a new treatment for xerostomia and hyposalivation.

"Patients suffering radiation-induced xerostomia face a need for new therapeutic options. RXRG001 introduces an innovative approach offering hope for my patients. We are proud to be the first site to treat a patient with RXRG001 and look forward to continuing to collaborate with RiboX and other investigative centers to rapidly enroll patients in this FIH trial. I am glad that our first patient is tolerating the investigational product well.", commented Principal Investigator, Henry T. Hoffman, MD, MS, FACS, Professor, Otolaryngology and Editor, Iowa Head and Neck Protocols of University of Iowa.

"We are privileged to work with Dr. Hoffman at University of Iowa and our other esteemed Principal Investigators whose patients battle for their quality of life under the profound impact of radiation-induced xerostomia, in aftermath of their cancer treatment and survivorship," shared Haifa Tyler, Head of Clinical Operations of RiboX, "It is an honor to initiate the first-ever circular RNA therapy clinical trial and now a pivotal moment in the dosing of our first patient."

"Today's accomplishment marks an important milestone for both RiboX and most notably for xerostomia patients. We are grateful to our patients and investigators for their contribution to our clinical trials. RiboX is committed to introducing more novel treatments to patients around the world by leveraging our innovative circular RNA technology." Yizhen Xu, MD, PhD, Chief Medical Officer of RiboX stated.

About RXRG001

RXRG001 is a proprietary product developed using innovative circular RNA technology. In recent years, circular RNA has emerged as the next generation RNA therapy due to its high protein expression efficiency, low immunogenicity, and manufacture stability. RXRG001 consists of the circular RNA coding human aquaporin 1 (hAQP1, a water channel protein of cell membranes), encapsulated in lipid nanoparticles (LNPs). RXRG001 is anticipated to increase saliva production by restoring water permeability via overexpression of hAQP1, therefore it alleviates dry mouth symptoms.  Non-clinical studies have demonstrated a favorable risk and benefit profile of RXRG001 in animal models. For instance, a single administration of RXRG001 led to a significant increased salivary flow which was sustained for about four weeks.

RXRG001 is the first-ever circular RNA therapy to receive FDA IND clearance back on October 25th, 2024.

About RiboX Therapeutics

RiboX is a globally operated biotech, dedicated to discovering and developing fully engineered circular RNA therapeutics, cofounded by Drs. Ling-Ling Chen, Dan Peer and Weiyi Zhang in 2021.  The company has operations in Princeton, NJ, USA, Rehovot, Israel and Shanghai, China. Circular RNA therapy is a novel modality, which is considered as the next generation RNA therapy. Compared to mRNA, circular RNA has a covalently closed single-stranded RNA structure that confers superior stability, lowers immunogenicity, and tunable protein expression, subsequently overcoming the current limitations of mRNA therapeutics and realizing the full potential of RNA medicines. 

RiboX's pipeline spans various therapeutic areas, including radiation-induced xerostomia, monogenic rare diseases, autoimmune diseases, and metabolic diseases. RiboX is committed to pioneering innovative research in next-generation RNA therapies, with a vision to improve the quality of life for patients worldwide.

For further details of the clinical trial, please visit:

• https://clinicaltrials.gov/study/NCT06714253
• https://www.riboxtx.com/sprinx-1

For further company information, please visit:  https://www.riboxtx.com

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