ASMB Assembly Biosciences Inc

Assembly Biosciences, Inc. (NASDAQ:ASMB), a clinical-stage biotechnology company advancing a new class of oral therapeutics for the treatment of hepatitis B virus (HBV) infection and novel oral live biotherapeutics for disorders associated with the microbiome, today announced that it will have three poster presentations at the upcoming Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting®), being held October 20-24 in Washington, DC.

Dr. Richard Colonno, Chief Scientific Officer for Assembly’s HBV program, commented, “These presentations highlight notable aspects of our HBV program, which aims to increase HBV cure rates with our novel, chemically differentiated Core protein Allosteric Modifiers (CpAMs). Phase 1a data on our first-generation CpAM shows that it is well tolerated, with favorable drug-like properties that support once daily dosing and initiation of our ongoing Phase 1b trials in chronic HBV patients. Preclinical data on our second generation CpAMs highlight their potent antiviral activity, favorable drug properties and inhibitory effects on cccDNA generation. Together with our clinical collaborators at Nanfang Hospital, we are also presenting intriguing new data on the half-life of existing cccDNA, using genetic markers of viral resistance in HBV patients who have failed on nucleoside treatment.”

Dr. Colonno added, “We are delighted with the progress we are reporting at this important scientific meeting and look forward to sharing more data as we advance our multiple HBV CpAM candidates over the coming year.”

Poster # 922Title: Preclinical Profile of Potent Second Generation CpAMs Capable of Inhibiting the Generation of HBsAg, HBeAg, pgRNA and cccDNA in HBV Infected CellsSession: HBV - New and Approved TreatmentDate: Saturday, October 21, 2017Time: 5:30pm-7:00PMPresenter: Richard Colonno, PhD., Chief Scientific Officer, Assembly BiosciencesAbstract Summary: The poster presents data showing that Assembly’s next generation CpAMs, including our recently nominated clinical candidate ABI-H2158, exhibit enhanced inhibitory potency against HBV replication and cccDNA generation, and maintain favorable drug properties. 

Poster # 926Title: Phase 1a Safety and Pharmacokinetics of ABI-H0731, a Novel Core Protein Allosteric Modifier (CpAM) For the Treatment of Chronic HBV InfectionSession: HBV - New and Approved TreatmentDate: Saturday, October 21, 2017Time: 5:30pm-7:00PMPresenter: Edward Gane, MD, Professor of Medicine, University of Auckland and Chief Hepatologist, Auckland City Hospital, and Uri Lopatin, MD, Chief Medical Officer, Assembly BiosciencesAbstract Summary: In a Phase 1a study, ABI-H0731 was well tolerated, with no serious adverse events. Reported adverse events that may have been drug-related were mild and/or transient. Pharmacokinetic results from the study confirm that ABI-H0731 possesses favorable drug-like properties, with once daily oral administration resulting in plasma concentrations that are predicted to provide potent inhibition of HBV replication.

Poster # 1503Title: Rapid Turnover of cccDNA in Chronic Hepatitis B Patients Who Have Failed Nucleoside Treatment Due to Emerging ResistanceSession: Hepatitis B: Virology, Immunology and PathogenesisDate: Sunday, October 22, 2017Time:5:30pm-7:00pmPresenter: Qi Huang, PhD., Vice President Virology Discovery, Assembly BiosciencesAbstract Summary: The persistence of covalently closed circular DNA (cccDNA) is a key feature of chronic HBV infection. Assembly scientists discuss studies conducted using clinical samples from chronic HBV patients who have failed prior nucleoside therapy to gain insights into the half-life of cccDNA. The study data suggest that cccDNA may decay faster than previously predicted, with little evidence for substantial pools of inactive cccDNA.

The poster abstracts are available at www.aasld.org/publications/hepatology-0

About Assembly BiosciencesAssembly Biosciences, Inc. is a clinical-stage public biotechnology company developing two innovative platform programs: an HBV program advancing a new class of oral therapeutics for the treatment of hepatitis B virus (HBV) infection and a microbiome program developing novel oral live biotherapeutics designed to address diseases associated with the microbiome. Assembly’s HBV program is advancing multiple drug candidates with the aim of increasing cure rates in patients with chronic HBV. The company's microbiome program consists of a fully integrated platform that includes a robust strain identification and selection process, methods for strain isolation and growth under current Good Manufacturing Practices and a patent-pending delivery system, GEMICEL®, which allows for targeted oral delivery of live biologic and conventional therapies to the lower gastrointestinal tract. Assembly is developing a robust pipeline of product candidates in multiple disease indications. For more information, visit www.assemblybio.com.

Forward-Looking Statement The information in this press release contains forward-looking statements regarding future events, including statements about the clinical and therapeutic potential of Assembly’s development programs. Certain forward-looking statements may be identified by reference to a future period or periods or by use of forward-looking terminology such as “predicted” “designed” or "developing."  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 Annual Report on Form 10-K for the year ended December 31, 2016, and Quarterly Report on Form 10-Q for the quarter ending June 30, 2017 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.

ContactsAssembly Biosciences, Inc.                                                                  

Investors:  Lauren Glaser                                                     (415) 521-3828lglaser@assemblybio.com         

Media:Barbara Lindheim(212) 584-2276barbara@assemblybio.com