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.
The new data described today expands on the
presentation entitled Safety and pharmacodynamics of the
GalNAc-siRNA AB-729 in subjects with chronic hepatitis B infection,
recorded on October 14, 2020 and presented on November 15, 2020 by
Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., from the University of
Hong Kong at The Liver Meeting Digital ExperienceTM, The American
Association for the Study of Liver Diseases (AASLD) Meeting.
The new data summarized below include HBsAg data for the
complete 60 mg every 4 weeks multi-dose cohort (N=7) at week 20,
and the first results for the AB-729 90 mg single-dose cohort of
HBV DNA positive subjects (N=5).
William Collier, President and Chief Executive
Officer of Arbutus, stated, “The positive data described today,
together with the strong safety and efficacy results presented by
Professor Yuen at AASLD yesterday, are encouraging and continue to
support our confidence in the therapeutic value of AB-729 as we
plan to move into Phase 2 clinical trials.”
Summary of new data
Repeat dosing of AB-729 60 mg every 4 weeks results in
continuous declines in
mean HBsAg through week 20
(Cohort E)
|
Mean (SE) Week 16N=7 |
Mean (SE) Week 20N=7 |
Mean (SE) Week 24N=3 |
Δlog10 HBsAg (IU/mL) |
-1.44 (0.18) |
-1.71 (0.18) |
-1.84 (0.10) |
Dr. Gaston Picchio, Chief Development Officer at
Arbutus stated, “Further follow up of the 60 mg every 4 weeks
multi-dose cohort confirmed continuous reductions in mean HBsAg at
week 20 (N=7), and in a subset of subjects (N=3) beyond this time
point, while being generally safe and well tolerated. Additionally,
the mean HBsAg declines and slopes of declines are similar between
single doses and repeat doses of AB-729 up to week 12. Importantly,
this suggests that dosing AB-729 as frequently as every 4 weeks may
not be necessary, and that AB-729 has the potential to be dosed
every 8 weeks or even every 12 weeks. This dosing strategy is being
investigated in other cohorts of the trial with results from the 60
mg every 8 week cohort expected before the end of
2020.”AB-729 90 mg single-dose
reduces HBsAg and HBV DNA in
HBV DNA positive chronic Hepatitis B
(CHB) subjects with mean
HBsAg declines similar
to those seen in HBV DNA
negative subjects (Cohort
D)
|
Mean (SE) Week 12N=5 |
|
Δlog10 HBsAg (IU/mL) |
-1.02 (0.13) |
|
Δlog10 HBV DNA (IU/mL) |
-1.53 (0.24) |
|
Dr. Picchio added, “It is also encouraging to observe that a
single 90 mg dose of AB-729 is capable of reducing HBsAg in HBV DNA
positive subjects to the same extent achieved in other single-dose
HBV DNA negative cohorts. Further, a single 90 mg AB-729 dose
substantially reduced HBV DNA as well as HBV RNA and HBcrAg.”
AB-729 was safe and well tolerated after single and
repeat doses
- No serious adverse
events or discontinuations due to adverse events
- No treatment-related
Grade 3 or 4 adverse events
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 Today
Arbutus will hold a conference call and webcast
today, 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
about the Company’s expectations to conduct Phase 2 combination
studies with AB-729 dosing as infrequently as every 8 or 12
weeks; the Company’s expectation that AB-729 could
be effective at dosing intervals of every 8 or even every 12 weeks;
the Company’s expectations that additional data results from the
AB-729 60 mg 8 week cohort will be available before the end of
2020; and 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 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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