Virion Therapeutics has dosed the first patients in a Phase Ib trial investigating VRON-0200 as a functional cure for chronic hepatitis B virus (HBV) infection.
The first-in-human study (NCT06070051) plans to enroll 48 patients in Hong Kong and New Zealand. Additional sites in the United States are planned.
The company said it expects preliminary data from the study to be released early next year.
The program is being carried out with the help of joint venture partner Marine Biomedical. The two companies joined forces in early October.
VRON-0200 uses one of Virion’s checkpoint modifiers to amplify and amplify patients’ T-cell responses to HBV infection. The drug candidate is administered via intramuscular injection and is designed to combat immune failure. In preclinical studies, the drug was shown to activate T cells that are not normally activated during chronic HBV infection.
The World Health Organization (WHO) estimates that 296 million people worldwide have chronic hepatitis B virus infection. Currently, there is no cure for the virus, and the standard treatment is antiviral therapy, of which seven drugs have been approved by the U.S. Food and Drug Administration (FDA).
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There are other ongoing trials investigating functional cures for hepatitis B. AMRS Research and Gilead Sciences both have the combination therapy in their respective Phase II trials.
Dr. Grace Wong, professor of medicine at the Chinese University of Hong Kong (CUHK) and principal investigator of the VRON-0200 study, said: “New treatments that can control or potentially cure chronic hepatitis B virus infection are easy to administer, and “they are well tolerated. Whether used alone or in combination with other treatments, it is much needed. “
Andrew Luber, Ph.D., CEO of Virion, added: “This first study using our first checkpoint modifier, gD, not only benefits patients with chronic hepatitis B, but also provides useful insights into our proprietary platform technology and pipeline. information, including VRON-0300, which is being developed for patients with advanced solid tumors.”
