Latest news with #hepatitisD
Yahoo
12-05-2025
- Health
- Yahoo
Vir's hepatitis B combo falls short in Phase II trial
Vir Biotechnology's 'functional cure' combination therapy has failed to meet the efficacy endpoints in a Phase II trial in hepatitis B. The company reported data from the 24-week point of the ongoing MARCH Phase II trial (NCT04856085) where just 17% (3/18) and 21% (3/14) of patients with baseline hepatitis B surface antigen (HBsAg) <1,000IU/mL receiving tobevibart and elebsiran without or with peginterferon, respectively, achieved undetectable HBsAg. The trial also evaluated tobevibart and elebsiran without or with peginterferon as a functional cure. This was achieved in 11% and 15% of patients, respectively. Functional cure for hepatitis B is defined as sustained undetectable HBsAg and hepatitis B virus DNA below the lower limit of quantification (0.05IU/mL) at 24 weeks post-end of treatment after discontinuing nucleoside reverse transcriptase inhibitors (NRTIs). The study also looked at a modified definition of functional cure that allowed brief increases in virus levels for up to 35 days. Using this measure, 11% of patients treated with tobevibart and elebsiran alone, and 23% of those who also received peginterferon, showed signs of a functional cure. Vir said the safety and tolerability profile of tobevibart and elebsiran remains consistent with prior studies. Previously, Vir said the investigational combo reduced hepatitis B surface antigens at the same 24-week time stamp. Chronic hepatitis B is a long-lasting, inflammatory liver disease caused by the hepatitis B virus. The World Health Organization estimates that 254 million people live with hepatitis B, and an estimated 1.1 million deaths a year are associated with the disease. Complications may include liver cirrhosis, liver failure and liver cancer. Vir Biotechnology presented the data at the 2025 European Association for the Study of the Liver (EASL) congress in Amsterdam. Tobevibart is a monoclonal antibody developed by Vir while elebsiran is an Alnylam-discovered siRNA. In a Phase II trial (NCT05461170) in hepatitis D, the combination was more effective, with all six patients showing sustained virologic response at the time of the last visit and all patients achieving hepatitis D virus RNA < limit of detection (LOD) or ≥ 2 log10 IU/mL decrease from baseline. Vir Biotechnology is waiting to gain a partner to advance the combination therapy to Phase III studies. A Phase III trial of the combination in hepatitis D is currently recruiting patients (NCT06903338). "Vir's hepatitis B combo falls short in Phase II trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Los Angeles Times
08-04-2025
- Health
- Los Angeles Times
Hepatitis D: A Deeper Look at the Most Severe Viral Hepatitis
Hepatitis D, also called HDV infection, is widely known as the toughest form of viral hepatitis. Although not as famous as some other liver diseases, its impact can be devastating for those who get infected. The big twist with hepatitis D is that it depends on another virus—hepatitis B—to survive and multiply. In other words, you need to be infected with hepatitis B virus (HBV) first, or at the same time, for HDV to become active [1, 7]. This can happen when someone catches both HBV and HDV at once (coinfection), or when HDV strikes later if a person is already living with chronic HBV (superinfection). Table of Contents HDV is an unusual type of virus, sometimes referred to as a defective RNA viroid. By itself, it can't do much. It actually relies on the hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) to make new copies. Because of this special arrangement, HDV gets passed along the same routes as HBV, mainly through contact with infected blood—like sharing contaminated needles or receiving tainted blood products [4, 8]. Vaccination against hepatitis B virus (HBV) is crucial as it effectively prevents hepatitis D infection by eliminating the necessary environment for HDV replication. Scientists have found eight genotypes, or strains, of HDV. Different genotypes are common in different places. Some of these strains can lead to worse complications, including faster liver damage, while others seem milder. But no matter which genotype a person has, any form of HDV infection can cause more harm to the liver than HBV alone ([2]). Hepatitis D exists worldwide but tends to show up more often in specific groups. The hepatitis delta virus (HDV) is transmitted primarily through contact with infected blood, similar to hepatitis B virus (HBV). People who inject drugs face a high risk, partly because of needle sharing. Additionally, folks who come from regions where hepatitis D is widespread might bring the virus with them, possibly spreading it to new locations. Figuring out exactly how many people have HDV can be tricky. Some studies rely on small groups, others use different tests, and that causes confusion about the true numbers [6]. However, experts estimate it may range anywhere from 12 to 72 million people globally. Compared to an HBV infection by itself, HDV can cause: Chronic infections with HDV significantly increase the risk of liver failure, cirrhosis, and liver cancer. Because HDV often speeds up these serious complications, people who have both HBV and HDV need to keep a close eye on their health to catch any warning signs early. Spotting HDV can be complicated. One reason is that many labs worldwide don't always have the specialized tests to detect it. Plus, in the early stages of infection, HDV might not appear in standard bloodwork. All of this makes it tough to get a quick diagnosis. Despite these hurdles, it's vital to find HDV as soon as possible, since proper diagnosis can help prevent severe liver problems later [7]. Early detection of chronic infections is crucial to prevent severe liver complications and improve patient outcomes. Doctors have used pegylated interferon-α (IFN-α) for a while to tackle HDV, but it doesn't always work well. Many patients deal with relapses after treatment, and side effects can be rough [5]. Effective management of chronic infection with HDV is essential to reduce the risk of severe liver disease and improve long-term health outcomes. Several new therapies are under study and, though still in development, they bring hope for people battling chronic HDV: These medications could transform how we care for people infected with hepatitis D, offering better outcomes and fewer complications. Because HDV relies on HBV, stopping the spread of HBV and preventing hepatitis B infection in the first place is the best way to guard against HDV. Some core prevention steps include: Hepatitis D is often called the toughest type of viral hepatitis for good reason. The complications of hepatitis D, including severe liver diseases and liver failure, underscore the need for early diagnosis and effective treatment. It makes hepatitis B more severe and can rapidly push the liver toward dangerous complications. Yet, thanks to ongoing research, there are more solutions today than ever before. Groundbreaking therapies, improved understanding of the virus, and broader vaccination programs offer new ways to beat HDV. Still, major hurdles remain. It's important to encourage wider access to HBV vaccination and better testing to catch HDV sooner. Ongoing studies on therapies like bulevirtide and lonafarnib could pave the way for safer and more effective treatment strategies. By raising global awareness and combining prevention with medical innovation, we stand a real chance of halting the harmful effects of HDV once and for all. [1] Menegale, F., Manica, M., Zardini, A., Guzzetta, G., Marziano, V., d'Andrea, V., Trentini, F., Ajelli, M., Poletti, P., & Merler, S. (2023). Evaluation of Waning of SARS-CoV-2 Vaccine-Induced Immunity: A Systematic Review and Meta-analysis. JAMA network open, 6(5), e2310650. [2] Wedemeyer, H., & Manns, M. P. (2010). Epidemiology, pathogenesis and management of hepatitis D: update and challenges ahead. Nature reviews. Gastroenterology & hepatology, 7(1), 31–40. [3] Yardeni, D., Heller, T., & Koh, C. (2022). Chronic hepatitis D-What is changing?. Journal of viral hepatitis, 29(4), 240–251. [4] Rizzetto M. (2015). Hepatitis D Virus: Introduction and Epidemiology. Cold Spring Harbor perspectives in medicine, 5(7), a021576. [5] Da, B. L., Heller, T., & Koh, C. (2019). Hepatitis D infection: from initial discovery to current investigational therapies. Gastroenterology report, 7(4), 231–245. [6] Post, Z., & Reau, N. (2023). What Is the Real Epidemiology of Hepatitis D Virus and Why so Many Mixed Messages?. Clinics in liver disease, 27(4), 973–984. [7] Lampertico, P., Degasperi, E., Sandmann, L., Wedemeyer, H., & Delta Cure 2022 Working Group (2023). Hepatitis D virus infection: Pathophysiology, epidemiology and treatment. Report from the first international delta cure meeting 2022. JHEP reports : innovation in hepatology, 5(9), 100818. [8] Pascarella, S., & Negro, F. (2011). Hepatitis D virus: an update. Liver international : official journal of the International Association for the Study of the Liver, 31(1), 7–21. [9] Mentha, N., Clément, S., Negro, F., & Alfaiate, D. (2019). A review on hepatitis D: From virology to new therapies. Journal of advanced research, 17, 3–15. [10] Farci, P., & Niro, G. A. (2012). Clinical features of hepatitis D. Seminars in liver disease, 32(3), 228–236.
Yahoo
12-02-2025
- Business
- Yahoo
Bluejay Therapeutics Appoints Mary Cromwell as Senior Vice President and Head of Technical Operations
REDWOOD CITY, Calif., Feb. 12, 2025 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases, today announced that Mary Cromwell, Ph.D., has joined its leadership team as Senior Vice President and Head of Technical Operations. "Mary is a seasoned biotech executive with a track record of exceptional leadership in manufacturing sciences, formulation, quality, supply chain management, process development and BLA submissions. She has played key roles in advancing therapeutic candidates from late-stage research through commercialization,' said Keting Chu, M.D., Ph.D., Founder and Chief Executive Officer of Bluejay Therapeutics. 'I am thrilled to welcome her to Bluejay Therapeutics as we continue our efforts to advance new therapeutic options for people living with chronic hepatitis D and chronic hepatitis B.' Dr. Cromwell has more than 30 years of experience in biotechnology operations and technical leadership. Most recently, she was Chief Technology Officer at Allakos, where she led technical operations and manufacturing strategy. Prior to that, Dr. Cromwell held a series of positions of increasing responsibility at Genentech/Roche, including Vice President and Head of Quality, Drug Substance, overseeing Quality Assurance and Quality Control for manufacturing. Her expertise spans end-to-end process and product technical development, quality and manufacturing. She was directly involved in the licensure of numerous Genentech/Roche products, including Avastin® and Perjeta® and served as a member of the Genentech Foundation Board. Dr. Cromwell holds a Ph.D. from the University of Colorado, Denver, a master's degree in biophysical chemistry from the University of California, Berkeley, and a bachelor's degree in chemistry from West Virginia University. Bluejay's lead product candidate brelovitug (BJT-778) recently received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of chronic hepatitis delta (CHD). Brelovitug also previously received EMA's PRIME and Orphan designation. About Bluejay TherapeuticsBluejay Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases. The company is currently investigating brelovitug (BJT-778) for the treatment of chronic hepatitis D (CHD) and chronic hepatitis B (CHB) virus infections. Additionally, Bluejay is advancing several innovative programs with the goal of developing a combination regimen to achieve a functional cure for chronic hepatitis B, including a proprietary TLR9 agonist (cavrotolimod) and a liver-targeted hepatitis B virus (HBV) transcript inhibitor (BJT-628). For more information on Bluejay Therapeutics, please visit the company's website at or follow the company on LinkedIn. Media Contact: Dan Boyle Orangefiery media@ 818-209-1692 Investor Contact: Peter GarciaCFO, Bluejay Therapeuticsir@ in to access your portfolio
