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Arbutus Reports Fourth Quarter and Year-end 2018 Financial Results and Describes Recent Clinical Accomplishments and Key 2019 Objectives
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Mar 07,2019
- Clinical trial results expected for AB-506, a potent capsid inhibitor, and AB-729, a subcutaneously administered RNAi agent targeting HBsAg
- Ongoing analyses of AB-452, a novel orally-available RNA destabilizer, with a go/no go decision expected in the second half of the year
- Ongoing characterization of the RNA destabilizer mechanism and several novel compounds in lead optimization
Conference Call and Webcast Scheduled Today at 4:30 PM ET
WARMINSTER, Pa., March 07, 2019 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, today reports its fourth quarter and year-end 2018 financial results and provides a description of recent clinical accomplishments and key 2019 corporate objectives.
“Arbutus is committed to developing a cure for chronic Hepatitis B which we maintain can be best achieved by employing a combination of therapeutic agents with distinct, yet complementary mechanisms of action,” said Dr. Mark J. Murray, President and Chief Executive Officer of Arbutus. “With multiple clinical trial initiations and data readouts expected throughout the year, 2019 promises to be an eventful and important year for Arbutus as we make progress toward our first novel combination regimen.”
Recent Clinical Accomplishments and Key 2019 Objectives
AB-506
In a Phase 1a/1b clinical trial, AB-506, Arbutus’ oral capsid inhibitor, successfully progressed through the healthy volunteer portion and is now being evaluated in HBV patients in the 28-day multiple dose Phase 1b portion of the trial. Top-line results of this Phase 1a/1b clinical trial are expected late in the second quarter of 2019.

A Phase 2 dose-finding and long-term safety trial of AB-506 in combination with an approved nucleoside analogue (NA) is expected to be initiated late in the second half of the year to support AB-506 use in future combination trials.

AB-506 inhibits HBV capsid assembly which inhibits HBV replication, a mode of action complementary to NAs; its use in patients is expected to reduce the levels of HBV DNA in the blood.      
AB-729
AB-729 is currently completing IND-enabling studies and is expected to begin a Phase 1a/1b clinical trial in the second quarter of 2019 and progress into HBV patients in the second half of the year.  AB-729 is an RNAi agent which blocks HBsAg expression and can be administered subcutaneously and we anticipate will be dosed monthly.  

A Phase 2 clinical trial combining AB-729, AB-506 and an approved NA is expected to initiate in the first half of 2020.  
AB-452 and RNA Destabilizer Program
Arbutus is developing oral RNA-destabilizers that have shown compelling anti-viral effects in multiple preclinical models. As a result of a nonclinical safety finding with our lead RNA-destabilizer, AB-452, we are conducting a series of in vitro and in vivo studies to further characterize the compound, its mechanism of action and pharmacokinetic profile before deciding to initiate clinical trials. A go/no go decision is expected in the second half of the 2019.

In parallel, the Company is also advancing a number of follow on compounds with distinct chemical scaffolds into the lead optimization stage.
Dr. Michael J. Sofia, Arbutus’ Chief Scientific Officer, stated, “We believe our RNA destabilizer program is amongst the most advanced programs of its kind in the HBV space and we remain confident that this mechanism represents a very relevant and important therapeutic target; success here could be very meaningful for patients and for Arbutus.”
ARB-1467
The Company has discontinued development of ARB-1467. Results from the ARB-1467 clinical trials confirmed the potential therapeutic value of an RNAi agent and informed the development of our next-generation RNAi agent, AB-729.
Early R&D Programs
The Company continues a robust discovery effort focused on back-up compounds for its current pipeline as well as discovery efforts focused on reawakening HBV patient’s immune response and on novel HBV-specific targets.  These programs include orally available compounds targeting PD-L1 and HBV cccDNA.
Cash Position and 2019 Cash Guidance
The Company ended the year with approximately $125 million  in cash, cash equivalents and short-term investments which we believe is sufficient to fund operations into 2020.  The Company expects to use approximately $70 to $75 million  in cash in 2019.
ONPATTRO Royalty Entitlement
ONPATTRO is an RN