PASADENA, Calif.–(BUSINESS WIRE)–May 30, 2018–
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it
has completed enrollment and dosing of all 5 planned cohorts of healthy
adult volunteers in the single-ascending dose portion of its ongoing
Phase 1/2 study of ARO-HBV, the company’s third generation
subcutaneously administered RNA interference (RNAi) therapeutic being
developed as a potentially curative therapy for patients with chronic
hepatitis B virus (HBV) infection. The company intends to submit a
late-breaking abstract with initial clinical data on ARO-HBV to the
Liver Meeting® 2018, the Annual Meeting of the American
Association for the Study of Liver Disease (AASLD), being held in
November.
AROHBV1001 (NCT03365947)
is a Phase 1/2 study evaluating the safety, tolerability, and
pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in
healthy adult volunteers, and evaluating the safety, tolerability, and
pharmacodynamic effects of multiple-ascending doses (MAD) of ARO-HBV in
patients with chronic HBV.
The SAD portion included 5 cohorts of 6 subjects per cohort. Each SAD
subject received a single-dose administration of either placebo or
ARO-HBV at dose levels of 35, 100, 200, 300, or 400 mg. The MAD portion,
which is ongoing, is designed to include up to 8 cohorts of 4 HBV
patients per cohort. Each MAD patient will receive 3 doses of ARO-HBV at
up to 4 dose levels (100, 200, 300, 400 mg). The first 2 MAD cohorts at
doses of 100 mg and 200 mg have been fully enrolled and the company
anticipates that the third cohort at a dose of 300 mg will be enrolled
shortly.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable
diseases by silencing the genes that cause them. Using a broad portfolio
of RNA chemistries and efficient modes of delivery, Arrowhead therapies
trigger the RNA interference mechanism to induce rapid, deep, and
durable knockdown of target genes. RNA interference, or RNAi, is a
mechanism present in living cells that inhibits the expression of a
specific gene, thereby affecting the production of a specific protein.
Arrowhead’s RNAi-based therapeutics leverage this natural pathway of
gene silencing.
For more information, please visit www.arrowheadpharma.com,
or follow us on Twitter @ArrowheadPharma.
To be added to the Company’s email list and receive news directly,
please visit http://ir.arrowheadpharma.com/email-alerts.
Safe Harbor Statement under the Private Securities Litigation Reform
Act:
This news release contains forward-looking statements within the
meaning of the “safe harbor” provisions of the Private Securities
Litigation Reform Act of 1995. These statements are based upon our
current expectations and speak only as of the date hereof. Our actual
results may differ materially and adversely from those expressed in any
forward-looking statements as a result of various factors and
uncertainties, including the safety and efficacy of our product
candidates, the duration and impact of regulatory delays in our clinical
programs, our ability to finance our operations, the future success of
our scientific studies, our ability to successfully develop drug
candidates, the timing for starting and completing clinical trials,
rapid technological change in our markets, and the enforcement of our
intellectual property rights. Our most recent Annual Report on Form 10-K
and subsequent Quarterly Reports on Form 10-Q discuss some of the
important risk factors that may affect our business, results of
operations and financial condition. We assume no obligation to update or
revise forward-looking statements to reflect new events or circumstances.
Source: Arrowhead Pharmaceuticals, Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180530005538/en/
Source: Arrowhead Pharmaceuticals, Inc.
Contacts:
Arrowhead Pharmaceuticals, Inc.
Vince
Anzalone, CFA
626-304-3400
ir@arrowheadpharma.com
or
Investors
and Media:
LifeSci Advisors, LLC
Brian Ritchie
212-915-2578
britchie@lifesciadvisors.com
www.lifesciadvisors.com