Assembly Biosciences Updates Pipeline Strategy, Focusing on Finite and Curative Therapies for Chronic Hepatitis B Virus Infec...
February 25 2021 - 4:00PM
Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage
biotechnology company developing innovative therapeutics targeting
hepatitis B virus (HBV), today announced that it is foregoing its
plans to initiate Phase 3 registrational studies of vebicorvir
(VBR, or ABI-H0731) as a chronic suppressive therapy (CST) to
concentrate its research and development efforts on finite and
curative HBV therapies. As part of this focused strategy on finite
and curative HBV therapies, Assembly Bio will prioritize its
portfolio of potent next generation core inhibitors and
combinations of VBR with complementary mechanisms of action, and
plans to rapidly advance multiple research programs focused on
novel targets and new mechanisms to the clinic.
The decision to not initiate the global registrational studies
of VBR as CST followed extensive discussions with leading experts
in the field and regulatory agencies, and with respect to the China
territory, discussions and agreement with the company’s partner,
BeiGene, Ltd. By redirecting the company’s resources previously
reserved for the CST registrational studies and other activities to
concentrate fully on pursuing finite and curative therapies,
Assembly Bio expects to be able to advance these initiatives
faster, while simultaneously extending its cash runway into
2023
“Many of us at Assembly Bio have spent our careers developing
drugs aimed at addressing tremendous unmet needs in viral diseases
and making a marked difference in patients’ lives. We remain
committed to the vision of freeing HBV patients from a lifetime of
treatment by advancing finite duration and curative therapies, and
we continue to believe that core inhibitors will be a central
component of these future regimens,” said John McHutchison,
AO, MD, Chief Executive Officer and President at Assembly Bio. “We
have the right team and resources in place to advance these
efforts, and we are excited about the opportunity before us.”
“Both of our companies are committed to addressing the highest
unmet medical need of patients,” said John Oyler, Chairman,
Co-Founder and Chief Executive Officer at BeiGene. “We support
Assembly Bio’s focus on pursuing a cure for HBV, and are hopeful
that the Assembly Bio team and their portfolio of core inhibitors
will bring finite and curative therapies closer to reality for the
nearly 90 million HBV patients in China.”
Assembly Bio’s HBV pipeline includes three clinical-stage core
inhibitor candidates and multiple research and discovery programs.
The company has two clinical studies underway with one more study
expected to begin during the first half of 2021.
Potent Next Generation Core Inhibitors
- ABI-H2158 (2158):
- Phase 2 study is ongoing with
interim data anticipated in the second half of 2021.
- Potent antiviral activity and a
favorable safety profile has been demonstrated in a Phase 1b
study.
- Candidate is ~10-fold more potent
than VBR in vitro against the formation of new cccDNA.
- ABI-H3733 (3733):
- Phase 1a study completed in healthy
subjects.
- Fourth Core Inhibitor Candidate:
- New candidate on track to be
nominated during the first half of 2021 with a potential
best-in-class profile, including greater potency against cccDNA
formation.
VBR + Nucleos(t)ide Analogue Reverse Transcriptase Inhibitor
(NrtI) in Combination with Other Complementary Mechanisms
- VBR + NrtI + interferon (peg-IFNα):
- Phase 2a triple combination study has been initiated.
- VBR + NrtI + RNAi:
- Phase 2a triple combination study including Arbutus’ RNAi
therapeutic AB-729 is expected to initiate in the first half of
2021.
- Additional Combinations:
- Further potential combination studies are under review to build
upon the VBR + NrtI antiviral “backbone” by evaluating the addition
of one or more complementary mechanisms of action.
Research Programs on New Targets
- Core Protein cccDNA Disruptors:
- A collaboration with Door Pharmaceuticals is underway to
discover and develop a novel class of HBV cccDNA disruptors that
target different phases of the HBV replication cycle distinct from
and complementary to those targeted by Assembly Bio’s existing
pipeline compounds.
- Novel HBV Targets:
- Assembly Bio has two additional internal programs underway
evaluating differentiated and undisclosed targets.
Assembly Bio’s Webcast
and Conference CallAssembly Bio will host a
webcast and conference call today at 5:00 p.m. ET/2:00 p.m. PT. The
live audio webcast may be accessed through the “Events &
Presentations” page in the “Investors” section of Assembly Bio’s
website at https://investor.assemblybio.com/events-presentations.
Alternatively, participants may dial (888) 771-4371 (domestic) or
+1 (847) 585-4405 (international) and refer to conference ID
50110189. To ensure timely access to the event, participants are
encouraged to connect to the call 15 minutes before the start time
or to utilize the webcast link for listen-only access.
The archived webcast will be available on Assembly Bio’s website
beginning approximately two hours after the event and will be
archived and available for replay for at least 30 days after the
event.
About HBVChronic hepatitis B virus (HBV)
infection is a debilitating disease of the liver that afflicts
approximately 270 million people worldwide, 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 Bio is a
clinical-stage biotechnology company committed to bringing finite
and curative therapies to the 270 million people living with
hepatitis B virus (HBV) worldwide. A pioneer in the development of
a new class of potent, oral core inhibitor drug candidates,
Assembly Bio’s approach aims to break the complex viral replication
cycle of HBV to free patients from a lifetime of therapy. Assembly
Bio’s strategy toward cure includes a leading portfolio of more
potent, next-generation core inhibitors, proof-of-concept
combination studies and a research program focused on the discovery
of novel HBV targets. 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
studies involving its HBV therapeutic product candidates, including
studies contemplated by Assembly Bio’s clinical collaboration
agreements, 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;
continued development and commercialization of Assembly Bio’s HBV
product candidates, if successful, in the China territory will be
dependent on, and subject to, Assembly Bio’s collaboration
agreement governing its activity in the China territory; Assembly
Bio’s ability to maintain financial resources necessary to continue
its clinical studies and fund business operations; any impact that
the COVID-19 pandemic may have on Assembly Bio’s business and
operations, including initiation and continuation of its clinical
studies 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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