Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage
biopharmaceutical company primarily focused on developing a cure
for people with chronic hepatitis B virus (HBV) infection as well
as therapies to treat coronaviruses (including COVID-19), today
announced the presentation of updated clinical data from an ongoing
Phase 1a/1b clinical trial (AB-729-001) with AB-729, its
proprietary GalNAc delivered RNAi compound. The presentation,
entitled Safety and pharmacodynamics of the GalNAc-siRNA AB-729 in
subjects with chronic hepatitis B infection, was presented by
Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., Chief of Division of
Gastroenterology and Hepatology, Department of Medicine, The
University of Hong Kong, Hong Kong, during a virtual oral session:
Hepatitis B: Therapeutics (New) at The Liver Meeting Digital
ExperienceTM, The American Association for the Study of Liver
Diseases Meeting.
Summary of presented data
Single-doses of AB-729 studied to date, 60 mg,
90 mg and 180 mg, resulted in comparable mean HBsAg declines at
week 12, followed by a sustained plateau phase. During the
multiple-dose portion of the trial, 60 mg of AB-729 dosed every 4
weeks resulted in continuous declines in HBsAg, reaching a mean of
–1.44 log10 IU/ML at week 16. Data beyond week 16 demonstrate
further declines in HBsAg with no plateau seen to date. AB-729 also
resulted in meaningful decreases in both HBV RNA and HBcrAg. AB-729
was generally safe and well tolerated. The presentation can be
accessed through the Investors section under Events &
Presentations of Arbutus' website at www.arbutusbio.com.
Repeat dosing of AB-729 60 mg every 4 weeks results in
continuous HBsAg declines beyond
week 12
|
Mean (SE) Week 12N=7 |
Mean (SE) Week 16N=7 |
Mean (SE) Week 20N=3 |
Δlog10 HBsAg (IU/mL) |
-1.10 (0.15) |
-1.44 (0.18) |
-1.73 (0.12) |
Professor Yuen stated “These are the first multi-dose data for
AB-729 and show continuous decline of HBsAg throughout the dosing
period. Importantly, AB-729 was generally safe and well tolerated.
These encouraging data support the continued development of AB-729
as a potential cornerstone of future combination regimens for the
treatment of chronic hepatitis B infection.”
Summary of clinical trial
design
AB-729-001 is an ongoing first-in-human clinical
trial consisting of three parts:
In Part 1, three cohorts of healthy subjects
were randomized 4:2 to receive single-doses (60 mg, 180 mg or 360
mg) of AB-729 or placebo.
In Part 2, non-cirrhotic, HBeAg positive or
negative, chronic HBV subjects (N=6) on a background of
nucleos(t)ide therapy with HBV DNA below the limit of quantitation
received single-doses (60 mg to 180 mg) of AB-729. An additional
cohort in Part 2 included 90 mg single-dose of AB-729 in HBV DNA
positive chronic HBV subjects.
In Part 3, chronic HBV subjects, HBV DNA
negative first and HBV DNA positive later, are receiving
multi-doses of AB-729 for up to six months.
About AB-729
AB-729 is an RNA interference (RNAi) therapeutic
targeted to hepatocytes using Arbutus’ novel covalently conjugated
N-acetylgalactosamine (GalNAc) delivery technology that enables
subcutaneous delivery. AB-729 inhibits viral replication and
reduces all HBV antigens, including hepatitis B surface antigen in
preclinical models. Reducing hepatitis B surface antigen is thought
to be a key prerequisite to enable reawakening of a patient’s
immune system to respond to the virus. In an ongoing single- and
multi-dose Phase 1a/1b clinical trial, AB-729 demonstrated positive
safety and tolerability data and meaningful reductions in hepatitis
B surface antigen.
About HBV
Chronic 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.
Conference Call and Webcast
Arbutus will hold a conference call and webcast
on Monday, November 16, 2020 at 8:00 am Eastern Time to provide an
AB-729 clinical update. You can access a live webcast of the call,
which will include presentation slides, through the Investors
section of Arbutus’ website at www.arbutusbio.com or directly at
Live Webcast. Alternatively, you can dial (866) 393-1607 or (914)
495-8556 and reference conference ID 7791835.
An archived webcast will be available on the
Arbutus website after the event. Alternatively, you may access a
replay of the conference call by calling (855) 859-2056 or (404)
537-3406, and reference conference ID 7791835.
About Arbutus
Arbutus Biopharma Corporation is a publicly
traded (Nasdaq: ABUS) biopharmaceutical company primarily dedicated
to discovering, developing and commercializing a cure for people
with chronic hepatitis B virus (HBV) infection. The Company is
advancing multiple drug product candidates that may be combined
into a potentially curative regimen for chronic HBV infection.
Arbutus has also initiated a drug discovery and development effort
for treating coronaviruses (including COVID-19). For more
information, please visit www.arbutusbio.com.
Forward-Looking Statements and
Information
This press release contains forward-looking
statements within the meaning of the Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
and forward-looking information within the meaning of Canadian
securities laws (collectively, “forward-looking statements”).
Forward-looking statements in this press release include statements
regarding the Company’s expectation that AB-729 could be the
cornerstone of future combination regimens for the treatment of
chronic hepatitis B infection.
With respect to the forward-looking statements
contained in this press release, Arbutus has made numerous
assumptions regarding, among other things: the effectiveness and
timeliness of preclinical studies and clinical trials, and the
usefulness of the data; the timeliness of regulatory approvals; the
continued demand for Arbutus’ assets; and the stability of economic
and market conditions. While Arbutus considers these assumptions to
be reasonable, these assumptions are inherently subject to
significant business, economic, competitive, market and social
uncertainties and contingencies, including uncertainties and
contingencies related to the ongoing COVID-19 pandemic.
Additionally, there are known and unknown risk
factors which could cause Arbutus’ actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements contained herein. Known risk factors
include, among others: anticipated pre-clinical studies and
clinical trials may be more costly or take longer to complete than
anticipated, and may never be initiated or completed, or may not
generate results that warrant future development of the tested drug
candidate; Arbutus may elect to change its strategy regarding its
product candidates and clinical development activities; Arbutus may
not receive the necessary regulatory approvals for the clinical
development of Arbutus’ products; economic and market conditions
may worsen; market shifts may require a change in strategic focus;
and the ongoing COVID-19 pandemic could significantly disrupt
Arbutus’ clinical development programs.
A more complete discussion of the risks and
uncertainties facing Arbutus appears in Arbutus’ Annual Report on
Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’
continuous and periodic disclosure filings, which are available at
www.sedar.com and at www.sec.gov. All forward-looking
statements herein are qualified in their entirety by this
cautionary statement, and Arbutus disclaims any obligation to
revise or update any such forward-looking statements or to publicly
announce the result of any revisions to any of the forward-looking
statements contained herein to reflect future results, events or
developments, except as required by law.
Contact Information
Investors and Media
William H. CollierPresident and CEO Phone: 267-469-0914Email:
ir@arbutusbio.com
Pam MurphyInvestor Relations ConsultantPhone: 267-469-0914Email:
ir@arbutusbio.com
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