SAN FRANCISCO, Oct. 02, 2018 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ:ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome, today announced that the company will have an oral presentation of the full data set from the Phase 1b study of ABI-H0731 at the upcoming American Association for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting®), being held November 9-13 in San Francisco.
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 Uri Lopatin, M.D., Chief Medical Officer. "Both trials are evaluating oral '731 at 300 mg once daily in combination with standard of care nucleos(t)ide therapy, with one trial enrolling treatment-experienced HBV patients with suppressed viral loads and the other enrolling treatment-naïve patients."
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.
Oral Presentation
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
Date:Sunday, November 11, 2018
Time:10:30am PT
Presenter: MF Yuen, MD, PhD, Chief of Division of Gastroenterology and Hepatology, Queen Mary Hospital, Hong Kong
About Assembly Biosciences
Assembly Biosciences, Inc. is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live synthetic biotherapeutic candidates with Assembly's fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology. For more information, visit assemblybio.com.
Forward-Looking Statements
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.
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