Hepatitis B Virus Hbv Infection Pipeline Insight
DelveInsight’s, “Hepatitis B Virus (HBV) Infection- Pipeline Insight, 2023” report provides comprehensive insights about 80+ companies and 90+ pipeline drugs in Hepatitis B Virus (HBV) Infection pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
- Global coverage
Hepatitis B Virus (HBV) Infection: Understanding
Hepatitis B Virus (HBV) Infection: Overview
Hepatitis B viral infection is a serious global healthcare problem. It is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). Hepatitis B virus is transmitted via percutaneous inoculation or through mucosal exposure with infectious bodily fluids. Oral-fecal transmission is possible but considerably rare. The incubation period of HBV infection is typically between 30 and 180 days, and while recovery is common in immunocompetent patients, a small percentage can progress to a chronic state, serologically defined as the presence of HBsAg for greater than six months. HBsAg is transmitted via blood contact or body secretions, and the risk of acquiring hepatitis B is considerably higher in individuals with close contact with HBsAg-positive patients.
The pathogenesis of liver disease in HBV infection is mainly immune-mediated, and in some circumstances, HBV can cause direct cytotoxic injury to the liver. HBsAg and other nucleocapsid proteins that are present on cell membranes promote T cells-induced cellular lysis of HBV-infected cells. Cytotoxic T cell response to HBV-infected hepatocytes is relatively ineffective; a significant majority of HBV DNA is cleared from the hepatic system prior to maximal T cell infiltration, suggesting that the immune response is likely more robust in the early stages of infection. The immune response may not be the sole etiology behind hepatic injury in hepatitis B patients. Hepatitis B-associated injury is also seen in post-liver transplant patients with hepatitis B that are on immunosuppressant therapy. The histological pattern that follows from this infection is termed fibrosing cholestatic hepatitis and is thought to be associated with an overwhelming exposure to HBsAg. This lends credence to the idea that hepatitis B may possess pathogenicity regardless of the immune system’s response.
Initial symptoms are nonspecific and may include anorexia, nausea, vomiting, abdominal pain, and jaundice. In cases of severe liver damage, patients can develop jaundice, hepatic encephalopathy, ascites, and gastrointestinal bleeding secondary to esophageal varices, coagulopathy, or infections. Diagnosis is based on serologic blood tests in patients with suspected signs and symptoms and associated risk factors for viral hepatitis.
The diagnosis of Hepatitis B is based on proper history taking, physical examination, laboratory works, and imaging. The diagnosis of hepatitis B relies on the appropriate history/physical and evaluation of serum or viral biomarkers. Viral serology of hepatitis B is usually detectable 1-12 weeks after initial infection with the primary viral marker being hepatitis B surface antigen (HBsAg). The presence of HBsAg rarely persists beyond 6 months after infection and typically precedes detectable quantities of the corresponding antibody to surface antigen (Anti-HBsAg). The period of time between the disappearance of HBsAg and the appearance of Anti-HBsAg is termed “the window period” or “serological gap.” During the window period, other viral serology could also be undetectable. HBsAg is the first virological marker to be detected thanks to its exposure on the viral surface and is indicative of an acute infection. All patients with chronic hepatitis B should be treated with antiviral medications and regularly monitored for efficient treatment. The current treatment is based on nucleostide analogs and pegylated interferons that save lives by decreasing liver cancer death, liver transplant, slow or reverse the progression of liver disease as well as the virus infectivity.
"Hepatitis B Virus (HBV) Infection- Pipeline Insight, 2023" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Hepatitis B Virus (HBV) Infection pipeline landscape is provided which includes the disease overview and Hepatitis B Virus (HBV) Infection treatment guidelines. The assessment part of the report embraces, in depth Hepatitis B Virus (HBV) Infection commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Hepatitis B Virus (HBV) Infection collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
The companies and academics are working to assess challenges and seek opportunities that could influence Hepatitis B Virus (HBV) Infection R&D. The therapies under development are focused on novel approaches to treat/improve Hepatitis B Virus (HBV) Infection.
Hepatitis B Virus (HBV) Infection Emerging Drugs Chapters
This segment of the Hepatitis B Virus (HBV) Infection report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Hepatitis B Virus (HBV) Infection Emerging Drugs
Bepirovirsen is an investigational antisense oligonucleotide (ASO) designed to specifically recognise the RNA that the hepatitis B virus uses to replicate itself in the infected liver cells (hepatocytes) and make the viral antigens (proteins) which facilitate chronicity of the disease by helping to avoid clearance by the immune system. The ASO recruits the liver’s own enzymes to eliminate the RNA by digesting it to an inactive form. The subsequent reduction in the levels of the RNA results in a decrease in both the virus and the production of viral antigen (HBsAg) by the hepatocytes, which can be measured by a drop in the HBV DNA and antigen levels in the circulating blood. Bepirovirsen has an additional property of stimulating immune responses via Toll-like receptor 8 (TLR8) which may help the immune system to achieve durable clearance of the virus from circulating blood.
Bepirovirsen (previously known as ‘ISIS 505358 or IONIS-HBVRX’) was discovered by and jointly developed with Ionis Pharmaceuticals. Bepirovirsen is one of the ASO HBV programme assets in-licensed by GSK from Ionis Pharmaceuticals in August 2019. Currently, the drug is in the Phase III stage of its development for the treatment of Hepatitis B Virus Infection.
VIR 2218: Vir Biotechnology
VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials. Currently, the drug is in the Phase II stage of its development for the treatment of Hepatitis B Virus Infection.
AB 729: Arbutus Biopharma
AB-729 is a subcutaneously-delivered RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. AB-729 targets hepatocytes using the novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology. AB-729 is currently being evaluated in a Phase IIa randomized, open-label, proof-of-concept clinical trial in combination with ongoing standard-of-care nucleos(t)ide analog therapy and short courses of Peg-IFNα-2a in 40 patients with chronic HBV infection.
AHB-137: Ausper Biopharma
AHB-137 is an unconjugated antisense oligonucleotide (ASO) with the potential to be a backbone for the functional cure of CHB. In June 2023, AusperBio announced that the Center for Drug Evaluation (CDE) of China has approved the Investigational New Drug (IND) application of AHB-137 to treat chronic hepatitis B (CHB) aiming for functional cure. AHB-137's highly potent antiviral activity in preclinical studies, along with its favorable pharmacokinetics and safety profile, garnered significant attention and recognition. Currently, the drug is in the Phase I stage of its development for the treatment of Hepatitis B Virus Infection.
Further product details are provided in the report……..
Hepatitis B Virus Infection: Therapeutic Assessment
This segment of the report provides insights about the different Hepatitis B Virus Infection drugs segregated based on following parameters that define the scope of the report, such as:
Major Players in Hepatitis B Virus Infection
There are approx. 80+ key companies which are developing the therapies for Hepatitis B Virus Infection. The companies which have their Hepatitis B Virus Infection drug candidates in the most advanced stage, i.e. phase III include, GSK.
DelveInsight’s report covers around 90+ products under different phases of clinical development like
- Late stage products (Phase III)
- Mid-stage products (Phase II)
- Early-stage product (Phase I) along with the details of
- Pre-clinical and Discovery stage candidates
- Discontinued & Inactive candidates
Route of Administration
Hepatitis B Virus Infection pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
Products have been categorized under various Molecule types such as
- Recombinant fusion proteins
- Small molecule
- Monoclonal antibody
- Gene therapy
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
Hepatitis B Virus (HBV) Infection: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Hepatitis B Virus (HBV) Infection therapeutic drugs key players involved in developing key drugs.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Hepatitis B Virus (HBV) Infection drugs.
Hepatitis B Virus (HBV) Infection Report Insights
- Hepatitis B Virus (HBV) Infection Pipeline Analysis
- Therapeutic Assessment
- Unmet Needs
- Impact of Drugs
Hepatitis B Virus (HBV) Infection Report Assessment
- Pipeline Product Profiles
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
Current Treatment Scenario and Emerging Therapies:
- How many companies are developing Hepatitis B Virus (HBV) Infection drugs?
- How many Hepatitis B Virus (HBV) Infection drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Hepatitis B Virus (HBV) Infection?
- What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Hepatitis B Virus (HBV) Infection therapeutics?
- What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Hepatitis B Virus (HBV) Infection and their status?
- What are the key designations that have been granted to the emerging drugs?