Assembly Biosciences Announces Completion of Enrollment in Two Phase 2a Studies with ABI-H0731 for Chronic Hepatitis B Virus
January 07 2019 - 7:00AM
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 completion of patient enrollment in two
Phase 2a studies with ABI-H0731, a potent core inhibitor, for the
treatment of HBV. The studies are ongoing, and the company
anticipates reporting interim results from both studies during Q2
of 2019.
“Completing patient enrollment in both of our first Phase 2
studies marks an important milestone for our ongoing HBV clinical
program and brings the potential of a cure closer to the millions
of patients suffering from this chronic disease,” said Derek Small,
President and Chief Executive Officer. “The data from these studies
will serve to inform the timelines of the HBV cure program as well
as the design of future registrational studies. We anticipate
sharing interim data from the ongoing studies at scientific
conferences this year. We want to express our gratitude to all the
investigators, caregivers and patients who have dedicated their
time and effort to participate in these studies at the many sites
open around the world.”
ABI-H0731-201 is a Phase 2a “viral antigen” proof-of-concept
study that enrolled HBeAg positive and negative patients whose
viral load is already suppressed on active nucleos(t)ide (‘Nuc’)
therapy. The enrolled patients continue their ‘Nuc’ therapy and
were randomized 3:2 to either placebo or ABI-H0731 for six months.
This study is designed to evaluate the effectiveness of ABI-H0731
in inhibiting the generation of new covalently closed circular DNA
(cccDNA). Based on previous studies, inhibition of new cccDNA
generation while existing cccDNA decays should manifest as a
decline in viral antigens HBsAg and HBeAg.
ABI-H0731-202 is a Phase 2a “viral load” study that enrolled
treatment-naïve HBeAg positive patients and is designed to evaluate
the de novo combination of ABI-H0731 and ‘Nuc’ therapy (entecavir)
to ‘Nuc’ monotherapy alone. This study is designed to assess the
benefit of combination therapy by comparing the relative rates of
HBV viral load declines over six months.
At the end of six months, patients from both studies have the
opportunity to rollover to an open label combination (ABI-H0731 +
Nuc) and continue treatment for up to an additional year. The data
generated over the course of the Phase 2a studies will help to
inform timelines and registration strategies for this novel class
of HBV therapies. The U.S. Food and Drug Administration (FDA)
recently issued draft guidance for HBV drug development1 reviewing
development considerations for direct acting antiviral approaches
such as Assembly’s core inhibitors.
In addition to ‘731, Assembly continues to advance its deep
pipeline of potent HBV core inhibitors with ABI-2158, its second
core inhibitor, in an ongoing Phase 1a study in healthy volunteers.
Data from this study is expected to be available in the first half
of 2019. The company is planning to advance its third core
inhibitor, ABI-H3733, into clinical trials in 2019.
1U.S. Department of Health and Human Services. Food and Drug
Administration. Center for Drug Evaluation and Research (CDER).
(2018 November) Chronic Hepatitis B Infection: Developing Drugs for
Treatment. Guidance for Industry. Washington, DC.
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM624695.pdf
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,
ABI-H2158 and ABI-H3733, 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
“anticipates”, “will,” 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 September 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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