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 additional clinical data from an ongoing Phase 1a/1b
clinical trial (AB-729-001) with AB-729, its proprietary GalNAc
delivered RNAi compound.
William Collier, President and Chief Executive
Officer of Arbutus, stated, “Throughout 2020, Arbutus has reported
data that demonstrate the robust safety and efficacy of AB-729 in
multiple patient cohorts. These data support advancing AB-729 into
phase 2a clinical studies in 2021 and further support our
confidence in its potential to become a cornerstone drug in future
combination regimens to cure chronic hepatitis B.”
Summary of new data
Repeat dosing of AB-729 60 mg every
4 and 8 weeks results
in comparable declines
in mean HBsAg through
week 16
Δlog10 HBsAg/(SE)
(IU/mL) |
Mean (SE) Week 12 |
Mean (SE) Week 16 |
Mean (SE) Week 24 |
Cohort E Q4W
(N=7) |
-1.10 (0.15) |
-1.44 (0.18) |
-1.84 (0.16) |
Cohort F Q8W
(N=7) |
-1.02 (0.11) |
-1.37* (0.08) |
N/A** |
*Mean determined based on N=6 since one subject has not reached
week 16.**Data not yet available since none of the subjects have
reached week 24.
Dr. Gaston Picchio, Chief Development Officer of
Arbutus, commented, “The mean reduction in HBsAg seen at week 16 in
Cohort F suggests that AB-729 could offer patients the advantage of
being dosed every 8 weeks versus every 4 weeks. Further dosing
should allow us to confirm this finding.”
Dr. Picchio added, “Importantly, safety
continues to be unremarkable. We have not seen any related Grade
3/4 AEs or treatment-related discontinuations in any cohorts to
date. In Cohort F, two subjects had asymptomatic ALT elevations not
considered AEs; one subject with Grade 1 ALT elevations prior to
trial entry has had intermittent Grade 2 elevations, while another
subject had a transient Grade 1 elevation which resolved with
continued treatment.
Further, in Cohort E, the two subjects
previously reported with Grade 2 and two subjects with Grade 1 ALT
elevations have improved to Grade 1 and Grade 0, respectively,
after week 24. All seven subjects in the cohort have consented to
continue dosing with AB-729 for an additional 6 months.”
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.
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
about advancing AB-729 into phase 2a clinical studies in 2021; the
Company’s suggestion that suggests that AB-729 could offer patients
the advantage of being dosed every 8 weeks versus every 4 weeks,
which could be confirmed via further dosing; and the potential that
AB-729 could be a cornerstone drug in future combination regimens
to cure 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 InformationInvestors and
MediaWilliam H. CollierPresident and CEOPhone:
267-469-0914Email: ir@arbutusbio.com
Pam MurphyInvestor Relations ConsultantPhone: 267-469-0914Email:
ir@arbutusbio.com
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