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
reports continued positive data from an ongoing Phase 1a/1b
clinical trial (AB-729-001) with AB-729, its proprietary GalNAc
delivered RNAi compound. These new data demonstrate that in chronic
HBV subjects, a single subcutaneous injection of 90 mg of AB-729
resulted in a mean HBsAg reduction of 1.23 log10 IU/mL at week 12.
William Collier, President and Chief Executive
Officer of Arbutus, stated, “The 90 mg single-dose 12-week data
coupled with our previously disclosed 60 mg single-dose 12-week
data mean that we now have two doses which have demonstrated
meaningful reductions in HBsAg with a favorable safety and
tolerability profile. We are currently dosing chronic HBV subjects
in four multi-dose cohorts using both the 60 mg (every 4- and
8-weeks) and 90 mg (every 8- and 12-weeks) doses to determine the
optimal dosing regimen for AB-729. We believe AB-729 will
potentially offer people with chronic HBV a well-tolerated low dose
treatment with a minimum of injections.”
Arbutus expects to present initial results from
its ongoing Phase 1a/1b clinical trial for the 60 mg multi-dose
cohorts, the 90 mg single-dose cohort in HBV DNA positive subjects,
as well as longer-term follow up of the 60 and 90 mg single-dose
cohorts, at an upcoming scientific meeting later this year. In
addition to the ongoing 60 mg multi-dose cohorts with subjects
dosed at 4- and 8-weeks, the Company has also initiated 90 mg
multi-dose cohorts with subjects dosed at 8- and 12-week
intervals.
Mean HBsAg changes from baseline:
|
60 mg Single-Dose Cohort (B) (N=6) |
90 mg Single-Dose Cohort (C) (N=6) |
Week 12 (day 84) mean log10 IU/mL (Standard Error of the Mean) |
-0.99 (0.24) |
-1.23 (0.18) |
Dr. Gaston Picchio, Chief Development Officer of
Arbutus, stated, “The mean HBsAg decline seen in the 90 mg
single-dose cohort is consistent with that seen in prior
single-dose cohorts. Importantly, the data demonstrate consistent
efficacy and a favorable safety profile at this intermediate dose.
These findings support the continued evaluation of the 90 mg dose
in the multi-dose portion of our ongoing clinical trial.”
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 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.
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.
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 Arbutus’ expectations regarding the timing and clinical
development of its product candidates; the potential for AB-729 to
be a well-tolerated low dose treatment for HBV with a minimum of
injections; Arbutus’ expectation to present AB-729 60 mg multi-dose
data and 90 mg single-dose data in HBV DNA positive subjects, as
well as longer-term follow up of the 60 and 90 mg single-dose
cohorts at an upcoming scientific meeting later this year; and
Arbutus’ expectations regarding the effect of the COVID-19 pandemic
on its business.
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. Collier President and CEO Phone: 267-469-0914 Email:
ir@arbutusbio.com Pam Murphy Investor Relations Consultant Phone:
267-469-0914 Email: ir@arbutusbio.com
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