Assembly Biosciences Announces FDA Fast Track Designation Granted to ABI-H0731 for the Treatment of Hepatitis B Virus Infection
INDIANAPOLIS and SAN FRANCISCO,
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
“More than one million individuals in the U.S. suffer from chronic Hepatitis B infection, which can progress to cirrhosis and liver cancer, eventually leading to death. Despite existing antiviral therapies, cures are rare, so the need for more effective and potentially curative treatments is tremendous,” said Uri Lopatin, MD, Chief Medical Officer of Assembly Biosciences. “We are encouraged that ABI-H0731 was granted Fast Track Designation. This will allow us to work closely with the
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 naïve 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.
About Assembly Biosciences
The information in this press release contains forward-looking statements regarding future events, including statements about the clinical and therapeutic potential of core inhibitors, including ABI-H0731, the difficulty of predicting the timing or outcome of
Source: Assembly Biosciences