Assembly Biosciences Announces Oral Presentation at 2018 AASLD
The oral presentation at AASLD will review final results of the Phase 1b study in patients with chronic hepatitis B (HBV) infection, including safety, tolerability and pharmacokinetics of ABI-H0731 (or ‘731), as well as quantitative changes in HBV DNA, RNA and viral antigens. ABI-H0731 was safe and well tolerated, with dose dependent antiviral effects at doses ranging from 100 to 400 mg given orally once daily, and RNA declines paralleled the observed DNA declines. The company presented interim results of the study at the Annual Meeting of the European Association for the Study of the Liver (EASL) in April.
“We are pleased with the final results from the Phase 1b study, with viral load responses and a safety profile that solidly support our clinical strategy in the two Phase 2a trials currently underway in HBV patients,” said
In July, the Company received FDA Fast Track Designation for ABI-H0731 and expects to report interim data from the Phase 2a trials during the first half of 2019. Assembly also plans to expand its clinical HBV pipeline later this year with the initiation of a Phase 1 study on its second, highly potent core inhibitor, ABI-H2158.
Title: Final Results of a Phase 1b 28-Day Study of ABI-H0731, a Novel Core Inhibitor, in Non-Cirrhotic Viremic Subjects with Chronic Hepatitis B
Session: Parallel 8: Novel Therapies for HBV
Room: 157/160, Moscone Center, North and South Buildings
Presenter: MF Yuen, MD, PhD, Chief of
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 and ABI-H2158, Assembly’s development programs, the results of clinical trials being predictive of future clinical trials, the initiation, progress and results of Assembly’s ongoing and planned clinical studies and the timing of these events. Certain forward-looking statements may be identified by reference to a future period or by use of forward-looking terminology such as “plan,” “upcoming,” “look forward,” “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 June 30, 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