Assembly Biosciences Announces Oral Presentation at 2018 AASLD
October 02 2018 - 7:05AM
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
PresentationTitle: Final Results of a
Phase 1b 28-Day Study of ABI-H0731, a Novel Core Inhibitor, in
Non-Cirrhotic Viremic Subjects with Chronic Hepatitis
BSession: Parallel 8: Novel Therapies for
HBVRoom: 157/160, Moscone Center, North and South
BuildingsDate: Sunday, November 11,
2018Time: 10:30am PTPresenter: MF
Yuen, MD, PhD, Chief of Division of Gastroenterology and
Hepatology, Queen Mary Hospital, Hong Kong
About Assembly
BiosciencesAssembly 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.
Contacts Assembly Biosciences,
Inc. Investors: Lauren Glaser (415) 521-3828
lglaser@assemblybio.com
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