With a single administration, XVIR-210, a nano-formulated prodrug of tenofovir, provided drug levels sufficient for chronic HBV treatment, HIV treatment, and HIV prophylaxis for over two months in animal studies
56-day biodistribution showed protective levels of tenofovir and its active metabolite in target tissues, including liver and lymphatic, with statistical superiority to tenofovir alafenamide (TAF) nano-formulated control
Exavir Therapeutics is selecting a candidate from tenofovir prodrug series to move into IND-enabling studies and pursue clinical development in chronic HBV, HIV treatment and prophylaxis, and HBV-HIV co-infection
NEW YORK and OMAHA, Neb., Sept. 16, 2021 (GLOBE NEWSWIRE) -- Exavir Therapeutics, a company dedicated to transforming the lives of patients living with or at risk for acquiring HIV and other viral infections, announced today the publication of preclinical data for XVIR-210, an investigational agent being developed as a long-acting antiviral for chronic HBV treatment, HIV treatment and prophylaxis, and HIV-HBV co-infection.
The research findings were published today in Nature Communications in an article titled “Transformation of tenofovir into stable ProTide nanocrystals with long-acting pharmacokinetic profiles”, and detailed drug product stability, in vivo pharmacokinetics, and preliminary toxicology studies supporting XVIR-210’s further development as a long-acting nucleotide antiviral with dual activity against HBV and HIV.
“We now have a second agent, XVIR-210, that can provide long-acting exposures of a backbone antiviral therapy, tenofovir. These results build on our previous efforts and the publication of preclinical data for our ultra-long-acting HIV integrase inhibitor, XVIR-110,” said Benson Edagwa, scientific co-founder of Exavir Therapeutics and Associate Professor in the Department of Pharmacology at the University of Nebraska Medical Center. “We are building an armamentarium of long-acting antivirals to combat HIV and other viral infections. Effective long-acting combinations will need to address multiple targets throughout the viral life cycle.”
As discussed in the publication, a single injection of XVIR-210, Exavir’s proprietary nano-formulated tenofovir prodrug, provided therapeutic exposures of tenofovir to rats for over two months. Widespread tissue biodistribution of tenofovir, and its active metabolite, tenofovir diphosphate, were observed in target tissues of interest for HIV and HBV infection, namely liver and lymphatic tissues. Preliminary toxicology studies, including body weight measurements, hematology, serum chemistry, and histopathology showed XVIR-210 was well tolerated.
“The current treatment paradigm for HBV treatment consists of daily oral tenofovir and interferon therapies with suboptimal cure rates and significant adverse effect burden. Investigational agents, while promising, are likely to be combined with tenofovir standard of care for optimal patient outcomes,” said Dr. Howard Gendelman, scientific co-founder of Exavir Therapeutics and Professor of Medicine at the University of Nebraska Medical Center. “Here, we have demonstrated the potential of our agent as a long-acting nucleotide backbone therapy for HBV, HIV, and importantly for HBV-HIV co-infection, where other long-acting antiretrovirals are ineffective.”
Chronic HBV is one of the most prevalent viral infections. It is estimated that nearly 300 million people are living with chronic HBV infection worldwide, with 1.5 million new infections, and nearly 800,000 deaths annually.
XVIR-210, also known as NM1TFV, is a novel tenofovir prodrug, which can be administered as an intramuscular injection. Preclinical pharmacokinetic and toxicology studies conducted to date support the development of XVIR-210 as a potential long-acting therapy for HBV, HIV treatment and prevention, and HBV-HIV co-infection.
About Exavir Therapeutics, Inc.
Exavir Therapeutics is a preclinical stage biotechnology company dedicated to eliminating HIV and other viral infections with a broad modality-agnostic approach, beginning with long-acting antiviral therapeutics.
Exavir’s pipeline includes several long-acting antiviral nanomedicines as well as an earlier stage HIV cure program that utilizes CRISPR nucleases and proprietary LNP formulations to precisely deliver pro-viral DNA excision payloads to tissues that are the target of HIV.