Assembly Biosciences Initiates Two Phase 2a Trials of ABI-H0731 for the Treatment of Hepatitis B Virus Infection
Key aim is to demonstrate that core inhibitor therapy combined with standard of care antivirals can offer curative potential for HBV
INDIANAPOLIS and SAN FRANCISCO,
“We are excited to initiate these next clinical studies, which will evaluate ABI-H0731 in combination with standard nucleos(t)ide therapy in patients with chronic HBV infection,” said
"Even with indefinite treatment with the currently available nucleoside and nucleotide inhibitors, we are not able to fully suppress viral replication, which will be necessary for patients to achieve a cure for chronic HBV," said
The first Phase 2a trial, ABI-H0731-201 (the “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. Approximately 45 patients will be randomized 3:2 to receive either daily ABI-H0731 (300 mg) 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 (HBsAg) and HBV E antigen (HBeAg) in subjects on combination therapy to those seen in subjects on monotherapy, as well as the safety and tolerability of ABI-H0731. Blood levels of HBsAg and HBeAg can be biomarkers for the presence of cccDNA in HBV infected liver cells. Accordingly, a decline in these markers would be expected to correlate with inhibition of cccDNA generation.
The second Phase 2a trial, ABI-H0731-202 (the “viral load trial”), is enrolling HBeAg positive HBV patients who are naïve to nucleos(t)ide treatment. Approximately 24 patients will be randomized 1:1 to receive either daily ABI-H0731 (300 mg) or placebo in combination with standard of care entecavir (0.5 mg) for six months. The viral load trial will assess the antiviral potency of the combination compared with entecavir alone. Endpoints include the speed and depth of viral suppression, as well as changes in biomarkers (HBsAg and HBeAg) for the presence of cccDNA, and the safety and tolerability of ABI-H0731.
Initial results from the 201 and 202 trials are anticipated in the first half of 2019. More information on the trials may be found on www.clinicaltrials.gov under the trial identifiers NCT03576066 and NCT03577171.
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 timing, size and results of Assembly’s planned clinical studies and the timing of reporting clinical trial results. Certain forward-looking statements may be identified by reference to a future period or by use of forward-looking terminology such as “will,” “expected,” and “potential.” Assembly intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by Assembly are more fully detailed under the heading “Risk Factors” in Assembly's Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 filed with the Securities and Exchange Commission. Except as required by law, Assembly assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Assembly Biosciences