Arbutus Announces Single-Dose Week 12 Data in Chronic Hepatitis B Subjects with 60 mg AB-729 Demonstrating a Significant and ...
May 18 2020 - 4:05PM
Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage
biopharmaceutical company focused on developing a cure for people
with chronic hepatitis B virus (HBV) infection, today reports
positive follow-up data from a Phase 1a/1b clinical trial
(AB-729-001) in chronic HBV subjects on nucleos(t)ide therapy who
received a single subcutaneous injection of 60 mg of AB-729, a
proprietary GalNAc delivered RNAi compound.
William Collier, President and Chief Executive
Officer of Arbutus, stated, “These new data further demonstrate the
robust activity of AB-729. At week 12, the 60 mg single-dose
achieved equivalent reductions in HBsAg as the 180 mg single-dose.
We are currently dosing chronic HBV subjects in a multi-dose cohort
with 60 mg of AB-729. These data keep us on track for achieving our
goal of delivering a combination therapy that includes HBsAg
reduction in chronic hepatitis B subjects.”
Mean HBsAg changes from baseline:
|
60 mg Single-Dose Cohort (N=6) |
180 mg Single-Dose Cohort (N=4) |
Day 29 mean log10 IU/mL (Standard Error of the Mean) |
-0.24 (0.13) |
-0.8 (0.38) |
Week 12 (day 84) mean log10 IU/mL (Standard Error of the Mean) |
-0.99 (0.24) |
-0.98 (0.22) |
Dr. Gaston Picchio, Chief Development Officer of
Arbutus, stated, “Importantly, throughout the 12 week period, not
only does AB-729 demonstrate robust HBsAg reduction, it does so
while remaining generally safe and well tolerated with no abnormal
transaminase values in any of the six subjects.”
Dr. Picchio added, “We are impressed by both the
magnitude and continuous reduction in HBsAg achieved with a single
60 mg dose. We believe that these features could provide a
competitive advantage with a low dose and reduced frequency of
injections. To this end, we are currently dosing chronic HBV
subjects in a multi-dose cohort with 60 mg at 4 week intervals and
also intend to evaluate 60 mg at 8 week intervals, which will begin
as soon as possible. As we previously announced we are also
exploring an additional 90 mg single-dose cohort. We expect data
from both the 60 mg multi-dose cohorts in the second half of the
year. We also expect week 12 90 mg single-dose data in the second
half of 2020.”
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 or 180 mg) of AB-729. An additional cohort in Part 2 is designed
to include 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, will receive multi-doses of AB-729 for up to
six months.
COVID-19
In December 2019 an outbreak of a novel strain
of coronavirus (COVID-19) was identified in Wuhan, China. This
virus continues to spread globally, has been declared a pandemic by
the World Health Organization and has spread to nearly every
country in the world. The impact of this pandemic has been, and
will likely continue to be, extensive in many aspects of society.
The pandemic has resulted in and will likely continue to result in
significant disruptions to businesses. A number of countries and
other jurisdictions around the world have implemented extreme
measures to try and slow the spread of the virus. These
measures include the closing of businesses and requiring people to
stay in their homes, the latter of which raises uncertainty
regarding the ability to travel to hospitals in order to
participate in clinical trials. Additional measures that have had,
and will likely continue to have, a major impact on clinical
development, at least in the near-term, include shortages and
delays in the supply chain, and prohibitions in certain countries
on enrolling subjects in new clinical trials. While we have
been able to progress with our clinical and pre-clinical activities
to date, it is not possible to predict if the COVID-19 pandemic
will negatively impact our plans and timelines in the future.
Conference Call and Webcast Today
Arbutus will hold a conference call and webcast
today, Monday, May 18, 2020 at 4:30 pm Eastern Time to provide a
corporate 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 8186276.
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 8186276.
About Arbutus
Arbutus Biopharma Corporation is a publicly
traded (Nasdaq: ABUS) biopharmaceutical company dedicated to
discovering, developing and commercializing a cure for people with
chronic Hepatitis B (HBV) infection. The Company is advancing
multiple drug product candidates that may be combined into a
potentially curative regimen for chronic HBV infection. For more
information, 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 our expectations regarding the timing and clinical
development of our product candidates; our expectation that certain
data from the 60 mg multi-dose and 90 mg single-dose cohorts will
be available in the second half of 2020; our plans to evaluate 60
mg at 8 week intervals as soon as possible; and our expectations
regarding the effect of the COVID-19 pandemic on our business.
With respect to the forward-looking statements
contained in this press release, Arbutus has made numerous
assumptions regarding, among other things: the timely receipt of
expected payments; 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; changes in Arbutus’ 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; and market shifts may require a change in strategic
focus; and the ongoing COVID-19 pandemic could significantly
disrupt our 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 CEOPhone: 604-419-3200Email:
ir@arbutusbio.com
Pam MurphyInvestor Relations ConsultantPhone: 604-419-3200Email:
ir@arbutusbio.com
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