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 data from its HBV core inhibitor
programs and related research will be highlighted during four
poster sessions – including two late-breakers – at the 2020
American Association for the Study of Liver Diseases (AASLD) The
Liver Meeting Digital ExperienceTM. The posters include data from
the company’s HBV core inhibitor research and development programs,
as well as a collaborative translational study using Assembly Bio’s
sensitive HBV nucleic acid assays.
“Findings from these studies are adding to a growing body of
clinical data that supports the differentiated safety profile of
vebicorvir in combination with nucleos(t)ide therapy,” said Ira M.
Jacobson, MD, Director of Hepatology at New York University Langone
Medical Center. “New treatment options for HBV patients are long
overdue and the addition of a core inhibitor to the
standard-of-care regimen may offer better chronic suppressive
therapy to a significant patient population. These longer-term
safety data, along with the demonstrated association of HBV pgRNA
and changes in HBV viral antigens presented at this conference, are
very encouraging and support the continued advancement of the
company’s core inhibitor programs.”
“Chronic hepatitis B virus infection is incredibly complex.
Through this research, we are proud to continue to contribute to
the scientific community’s understanding of hepatitis B and the
importance of deepening virologic suppression as it relates to both
improving chronic suppressive therapy and reducing downstream
clinically important liver-related events,” said John
McHutchison, AO, MD, Chief Executive Officer and President at
Assembly Biosciences. “Further, these data highlight the potential
of our more potent core inhibitor candidates, ABI-H2158 and
ABI-H3733. We believe that core inhibitors represent a significant
advancement in the HBV field and we remain focused on upcoming
milestones, including planned Phase 3 registrational trials of
vebicorvir in China and globally in the first half of
2021.”
The Liver Meeting Digital Experience 2020
Presentations:The posters will be made available on the
“Events and Presentations” page in the Investors section of
assemblybio.com.
Vebicorvir (VBR, or
ABI-H0731), Assembly Bio’s Lead HBV Core
InhibitorPoster Presentation 820: Analysis of the
longer-term safety profile of the hepatitis B virus core inhibitor
VBR in an open-label extension studyPresenter: Ira M. Jacobson, MD,
Director, Hepatology, NYU Langone Health
This poster includes data from a controlled comparison of 24
patients receiving placebo + nucleos(t)ide analogs (NrtI) for 24
weeks versus 95 patients receiving Assembly Bio’s lead core
inhibitor product VBR + NrtI for up to 1.5 years. Data support the
differentiated safety profile and continued development of VBR
combination therapy.
Key Results:
- The safety profile of combination treatment with VBR+NrtI was
similar to placebo+NrtI over a 24-week controlled-comparison and
was stable with longer-term treatment of VBR+NrtI up to 1.5
years.
- Rashes without systemic involvement observed with VBR+NrtI
treatment were predominantly Grade 1 resolving without VBR+NrtI
interruption.
- There was no pattern of increased alamine aminotransferase
(ALT) and/or aspartate aminotransferase (AST), indicative of
hepatoxicity.
Late-Breaking Poster LP37: Changes in viral
antigens are more strongly associated with HBV pgRNA than HBV DNA
in studies of vebicorvir and NrtI in treatment-naive patients with
chronic HBV infectionPresenter: Mark Sulkowski, MD, Medical
Director, Viral Hepatitis Center, Johns Hopkins University School
of Medicine
This poster details the results of post hoc analyses of data
from studies of VBR in treatment naïve patients with HBeAg positive
chronic HBV infection to better understand the correlations between
changes in HBV DNA and pgRNA with those of other HBV antigens. Two
approaches were used: correlation analyses with a Pearson’s
coefficient and a Mixed-Effects Model for Repeated Measures. These
results demonstrate the importance of pgRNA as a meaningful
biomarker for chronic HBV.
Key Results:
- Changes in other HBV antigens are more strongly associated with
the change in pgRNA compared with the change in HBV DNA.
- Correlations between pgRNA and HBeAg and HBcrAg were greater
relative to the correlations with HBsAg, likely due to the
substantial contribution of HBV integrants to HBsAg levels.
- A >2 log10 decline in pgRNA in patients receiving VBR +
entecavir (ETV) more significantly predicted the decline in the
HBeAg and HBcrAg consistent with the second phase decline with core
inhibitor treatment reflecting reduction in cccDNA pools.
Assembly Bio’s Next-Generation
of Core InhibitorsLate-Breaking Poster
LP45: Amino acid substitutions in the inhibitor binding pocket of
HBV core protein confer differential changes in susceptibility to
three generations of HBV core inhibitorsPresenter: Dawei Cai, PhD,
Senior Scientist, Assembly Bio
This poster describes the in vitro resistance profiles of
Assembly Bio’s first-generation core inhibitor, VBR, and
next-generation core inhibitor candidates ABI-H2158 (2158) and
ABI-H3733 (3733). Researchers evaluated the antiviral activity of
these candidates against known substitutions to the core inhibitor
binding pocket. They also assessed whether these substitutions
affect the ability of core inhibitors to block cccDNA formation as
well as HBV replication through inhibition of pgRNA
encapsidation.
Key Results:
- 2158 and 3733 showed greater potency in terms of preventing
cccDNA formation compared with VBR and had more favorable
resistance profiles against a panel of substitutions.
- ETV retains activity against all tested core protein
substitutions suggesting that combination therapy with NrtIs will
prevent viral breakthrough due to pre-existence or potential
emergence of core protein substitutions, consistent with the
current clinical data.
Use of Assembly Bio’s Highly Sensitive
HBV Assays to Characterize
the Association of HBV
with HCCPoster 738: Persistently detectable serum HBV
pgRNA is associated with subsequent HCC development in chronic
hepatitis B patients receiving chronic NrtI
treatmentPresenter: Lung-Yi Mak, MBBS, MRCP, PDipID, FHKCP,
FHKAM Department of Medicine, Queen Mary Hospital, The University
of Hong Kong, Hong Kong
In this poster, researchers detail findings from a case control
study to assess whether residual HBV viraemia is associated with
the development of hepatocellular carcinoma (HCC), the most common
type of primary liver cancer. The study evaluated 104 chronic HBV
patients, 39% of whom had cirrhosis, on ≥ 3 years ETV with
unquantifiable HBV DNA by standard assays. Findings highlight the
need for more potent viral suppression to further reduce the risk
of HCC.
Key Results:
- More sensitive assays revealed that patients still had ongoing
replication as evidenced by detection of HBV DNA and pgRNA.
- More than 50% of chronic HBV patients on ETV with HBV
DNA<LLOQ (lower limit of quantification) by standard assay had
persistent viraemia as determined by a more sensitive HBV DNA
assay.
- Detectable viral nucleic acids (HBV DNA and/or pgRNA) were
associated with a higher 2-year risk of HCC development.
About HBVChronic hepatitis B virus (HBV)
infection is a debilitating disease of the liver that afflicts over
250 million people worldwide with up to 90 million people
in China, as estimated by the World Health Organization.
HBV is a global epidemic that affects more people than hepatitis C
virus (HCV) and HIV infection combined—with a higher morbidity and
mortality rate. HBV is a leading cause of chronic liver disease and
need for liver transplantation, and up to one million people
worldwide die every year from HBV-related causes.
The current standard of care for patients with chronic HBV
infection is life-long suppressive treatment with medications that
reduce, but do not eliminate, the virus, resulting in very low cure
rates. There is a significant unmet need for new therapies to treat
HBV.
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 improve the treatment options available to
chronically infected patients. The microbiome program is developing
novel oral live microbial biotherapeutic candidates with Assembly’s
fully integrated platform, including a robust process for strain
identification and selection, GMP manufacturing expertise and
targeted delivery to the lower gastrointestinal tract with the
GEMICEL® technology. For more information, visit
assemblybio.com.
Forward-Looking StatementsThe information in
this press release contains forward-looking statements that are
subject to certain risks and uncertainties that could cause actual
results to materially differ. These risks and uncertainties
include: Assembly Bio’s ability to initiate and complete
clinical trials involving its HBV therapeutic product candidates in
the currently anticipated timeframes; safety and efficacy data from
clinical studies may not warrant further development of Assembly
Bio’s product candidates; clinical and nonclinical data presented
at conferences may not differentiate Assembly Bio’s product
candidates from other companies’ candidates; Assembly Bio may not
observe sustained virologic response in patients who stop
therapy in Study 211; Assembly Bio’s ability to maintain financial
resources necessary to continue its clinical trials and fund
business operations; any impact that the spread of the coronavirus
and resulting COVID-19 pandemic may have on Assembly Bio’s business
and operations, including initiation and continuation of its
clinical trials or timing of discussions with regulatory
authorities; and other risks identified from time to time in
Assembly Bio’s reports filed with the U.S. Securities and
Exchange Commission (the SEC). You are urged to consider
statements that include the words may, will, would, could, should,
might, believes, hopes, estimates, projects, potential, expects,
plans, anticipates, intends, continues, forecast, designed, goal or
the negative of those words or other comparable words to be
uncertain and forward-looking. Assembly Bio 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. More information about Assembly Bio’s risks and
uncertainties are more fully detailed under the heading “Risk
Factors” in Assembly Bio’s filings with the SEC, including its
most recent Annual Report on Form 10-K, Quarterly Reports on Form
10-Q and Current Reports on Form 8-K. Except as required by law,
Assembly Bio assumes no obligation to update publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Investor ContactAssembly
Biosciences, Inc.Lauren GlaserSenior Vice President, Investor
Relations and Corporate Affairs(415)
521-3828lglaser@assemblybio.com
Media ContactSam Brown Inc.Audra Friis(917)
519-9577ASMBMedia@sambrown.com
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