FDA grants ABI-H0731 fast-track determination for treatment of HBV infection patients

recently,
the U.SFDA, which has been awarded adrugfor the treatment of patients with chronic hepatitis B virus (HBV) infection,announcedABI-H0731, a core protein inhibitor for Assembly Biosciences' oral treatment of HBV, is currently undergoing two global clinical phase 2a proof-of-concept studies in which patients are being recruitedAssembly Biosciences recently launched two multicenter, randomized, placebo-controlled 2a
trials of ABI-H0731(which are actively recruiting patients in multiple locations in the United States and around the world)Among them, ABI-H0731-201 "viral antigen test" is recruiting HBeAg-positive hepatitis B virus infection patients, the viral load has been inhibited by standard nucleoside therapyPatients in the group will be randomly treated with daily ABI-H0731 or placebo supplemented by nucleoside analogues lasting 6 monthsThe "viral antigen test" will compare the combination therapy to the decline of HBV S antigens and HBV E antigens with standard nucleoside analogue monotherapy, as well as safety and tolerabilityanother ABI-H0731-202 "viral load test" for HBV patients who were hBeAg-positive without nucleoside therapy, who were randomly treated daily for 6 months with a bono-H0731 or placebo-joint endikavirThis "viral load test" will assess the antiviral resistance of the combination drug and the nitikavir monotherapy to viral DNA suppression, as well as the safety and tolerance of both groupsPreliminary results of both studies are expected to be completed in the first half of 2019 　　ABI-H0731 is a highly selective and powerful multi-core protein deconclinomorphic regulator (CpAMs) developed by Assembly Biosciences and derived from different chemical series CpAMs have an impact on several key points in the functioning of core proteins in the HBV life cycle, altering the activity of core proteins critical to HBV survival, and also performing antiviral effects by interfering with multiple aspects of HBV replication, including cccDNA 　　The ABI-H0731 program has focused on improving functional healing rates in patients with chronic HBV infection In addition to ABI-H0731, the company's other CpAM candidate product (ABI-H2158)