Hepatitis B is functionally cured! A single subcutaneous injection of RNAi therapy AB-729 has a significant effect!

PharmaceuticalNetwork, May 21 (Upi) -- Arbutus Biopharma is a clinical biopharmaceutical company focused on developing drugs to treat chronic hepatitis B virus (HBV) infectionRecently, the company released positive follow-up data for a Phase Ia/Ib clinical trial (AB-729-001)The data came from a single dose of 60mg AB-729, in which chronic HBV patients who were being treated with background nucleoside (acid) therapy received a single subcutaneous injection of 60mg dose AB-729Data show that the 60 mg dose of a single subcutaneous injection AB-729 significantly and lastingly reduced the level of hepatitis B surface antigen (HBsAg)AB-729 is a subcutaneous injection RNAi therapy that targets HBV replication and inhibition of antigen production, including hepatitis B surface antigen (HBsAg)In both in vitro and in vitro preclinical models, AB-729 showed strong and long-lasting reduction of HBsAg levelsInhibition of HBV protein, especially HBsAg, is thought to eliminate the inhibition of T-cell and B-cell activity against HBV, helping to restore the patient's own immune response to HBV, thus providing a potential functional cure for chronic HBV patientsAB-729 uses GalNAc conjugate technology, which enables subcutaneous administration to be more potent and durable, with a broad therapeutic indexCurrently, givlaari (givosiran, subcutaneous preparation) using GalNAc technology has been approved by the U.SFDA in January 2020 for the treatment of adult patients with acute hepatic rickets (AHP)The drug is the second RNAi drug approved worldwide and the first global approval for GalNAc-linked RNA therapy, marking a major milestone in the development of precision gene drugsthe ia/Ib phase study data published this time showed that in the single dose of 60 mg dose AB-729 cohort, the treatment of HBaAg average reduction of 0.99log10 IU/mL, and the total follow-up period, the liver function examination of the most commonly used 2 types of transaminase - acelanineaminoine (ALT) and temporyatoinaminotoase transfer (AST) values normallyThe study's 90mg single-dose cohort and 60mg multi-dose cohort are expected to have data in the second half of 2020William Collier, President and CEO of Arbutus, said: "These new data are further evidence of the strong activity of the AB-729In week 12, 60 mg of single administration decreased by the same amount as 180 mg of single administration compared to a single administrationWe are currently giving 60 mg dose ab-729 treatment to patients with chronic hepatitis B in multi-dose queues These data enable us to continue to move forward towards our goal of providing patients with chronic hepatitis B with a combination of treatment strains that reduce HBsAg levels Dr Gaston Picchio, Chief Development Officer, Arbutus, said: "It is important that ab-729 not only showed a strong HBsAg reduction throughout the 12-week study period, but also maintained overall safety and good tolerance, with no abnormal transaminase in any of the six subjects Dr gaston Picchio, , added: "We were impressed by the hBsAg reduction and the continued reduction achieved in a single 60 mg dose ab-729 We believe that these features can provide a competitive advantage in low doses and low injection frequencies To this end, we are currently in a multi-dose queue to give patients with chronic hepatitis B a 4-week interval for medication In addition, the evaluation of the 8-week programme at 60 mg intervals will be launched shortly As we announced earlier, we are also exploring an additional 90 mg single-dose cohort We expect data for the 60 mg multi-dose group to be available in the second half of the year We also expect to obtain 12-week data of 90 mg in single doses in the second half of 2020 "
Clinical Trial Design Summary: AB-729-001 is the first ongoing human clinical trial consisting of three parts: in Part 1, three groups of subjects randomly received a single dose (60 mg, 180 mg, 360 mg) of AB-729 or placebo at a 4:2 ratio In Part 2, non-cirrhosis, HBeAg positive or negative, chronic HBV subjects receiving background nucleoside (acid) therapy, and HBV DNA below the quantitative limit (N-6) received a single dose (60 mg or 180 mg) AB-729 Another queue in Part 2 was designed to include a single dose of 90 mg AB-729 in chronic HBV subjects with HBV DNA positive In Part III, patients with chronic hepatitis B, first HBV DNA-negative patients and then HBV DNA-positive patients, will receive multiple doses of AB-729 treatment for 6 months 　　HBV's main therapeutic target (photo source
-DOI: 10.1080/13543784.2017.1333105 ) is a life-threatening chronic ally of hepatitis B (CHB) a toxic liver infection that can lead to cirrhosis (liver tissue scarring) and liver cancer after long-term chronic infection Hepatitis B is a global public health problem that affects 292 million people worldwide, the World Health Organization (WHO) says Although there is a preventive vaccine, the cure rate for infected people remains low and most patients will receive life-long treatment At present, hepatitis B drugs on the market can only inhibit virus replication, not remove the virus Drugs based on RNA interference (RNAi) and antonym RNA technology can find, bind and destroy HBV RNA transcripts in a highly specific manner, silence all HBV gene products, block the production of viral proteins, and intervene upstream in the reverse transcription process of the current care nucleotides and nucleotide analogues The elimination of viral protein is expected to restore the body's natural immune defense system to the immune response of HBV, remove the virus, achieve functional cure Such drugs are expected to revolutionise the treatment of hepatitis B at present, a number of pharmaceutical companies are using RNAi and antisense RNA technology to develop drugs to treat chronic hepatitis B, in addition to Arbutus (GalNAc-RNAi drug AB-729), including Johnson/Arrowhead (JNJ-3989), formerly known as ARO-- HBV), Ionis/GlaxoSmithKline (Antisense RNA Drugs: IONIS-HBVRx, IONIS-HBV-LRx), Vir/Alnylam (VIR-2218), Roche/Dicerna Corporation (DCR-HBVS), etc original origin: Arbutus Announces Single-Dose Week 12 Data in Chronic Hepatitis B Subjects with 60 mg AB-729 Lling a Major and Continuous And Reduction In HBsAg