INDIANAPOLIS, Feb. 16, 2017 (GLOBE NEWSWIRE) -- 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 successful completion of the dose ranging portion of its Phase 1a/1b trial of ABI-H0731, the company’s lead Core protein Allosteric Modulator (CpAM) in development for the treatment of chronic HBV infection.
The Phase 1a study assessed the safety, tolerability and pharmacokinetics of ABI-H0731 in healthy volunteers. Favorable results from this segment of the study allow Assembly to advance ABI-H0731 into a Phase 1b study, which will assess its safety, pharmacokinetics and preliminary antiviral efficacy in patients with chronic HBV infection. The Phase 1b trial is expected to begin later this year. The company intends to report the results of the Phase 1a study at a scientific conference during 2017.
Separately, Assembly announced presentations at two upcoming conferences.
- 26th Conference of the Asian Pacific Association for the Study of the Liver (APASL) – Shanghai, China
Date/Time: Friday, February 17, 2017 at 10:20 am
Presenter: Qi Huang, PhD, Senior Director, Biology, Assembly Biosciences
Topic: Dual Mechanism of Actions of Novel HBV Core Protein Allosteric Modifiers (CpAMs): Inhibiting Viral Replication and Blocking cccDNA Formation.
Date/Time: Saturday, February 18, 2017 at 7:45 am
Presenter: Richard Colonno, PhD, Chief Scientific Officer of HBV, Assembly Biosciences
Topic: Second Wave of HBV Antivirals
The presentations will be available on the events page of the company’s website at www.assemblybio.com
- RBC Capital Markets 2017 Global Healthcare Conference - New York
Date/Time: Thursday, February 23, 2017 at 9:00 am ET
Presenter: Miguel Barbosa, PhD, Chief Scientific Officer, Microbiome Program, Assembly Biosciences
About Assembly Biosciences
Assembly 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 “intends,” “expected” 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. Factors that may cause such a difference include: Assembly may experience delays in the completion of its clinical trials (whether caused by competition, adverse events, patient enrollment rates, shortage of clinical trial materials, regulatory issues or other factors); risks that data from its clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of Assembly’s product candidates; risks that early stage preclinical data may not be indicative of subsequent data when expanded to additional nonclinical models or to subsequent clinical data; risks that evolving competitive activity and intellectual property landscape may impair Assembly’s ability to capture value for the technology. 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, 2015, and Quarterly Report on Form 10-Q for the quarter ending September 30, 2016 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.