Assembly Biosciences receives fast track designation for ABI-H0731 for HepB
Assembly Biosciences announced that the U.S. Food and Drug Administration has granted Fast Track designation to ABI-H0731 for the treatment of patients with chronic Hepatitis B infection. ABI-H0731 is Assembly's lead oral HBV core inhibitor, which is being evaluated in two global Phase 2a proof of concept studies that are currently enrolling patients. The Fast Track program is intended to facilitate the development and review of drug candidates that treat serious conditions and fill an unmet medical need. A drug candidate with Fast Track designation is eligible for greater access to the FDA for the purpose of expediting the drug product candidate's development, review and potential approval. Assembly recently initiated two multi-center, randomized, placebo controlled Phase 2a trials of ABI-H0731, which are actively recruiting and dosing subjects at multiple locations in the U.S. and globally. The ABI-H0731-201 "viral antigen trial" is enrolling HBeAg positive HBV patients whose viral load has already been suppressed on a standard of care nucleos(t)ide therapy. Patients will be randomized to receive either daily ABI-H0731 or placebo in addition to their continued nucleos(t)ide therapy for six months. The viral antigen trial will compare declines in HBV S antigen and HBV E antigen as well as safety and tolerability of the combination therapy to that of patients on standard-of-care nucleos(t)ide therapy alone. In the ABI-H0731-202 "viral load trial," HBeAg positive HBV patients are being enrolled who are naive to nucleos(t)ide treatment and will be randomized to receive either daily ABI-H0731 or placebo in combination with entecavir for six months. The viral load trial will assess the antiviral potency as measured by viral DNA suppression as well as safety and tolerability of the combination compared with entecavir alone. Initial results from both studies are anticipated in the first half of 2019.