Results demonstrate that AB-506 is a potent capsid inhibitor
Phase 1a/1b clinical trial to continue with the enrollment of further cohorts
Conference call and webcast scheduled today at
Summary of preliminary results with AB-506
“While ALT flares have occurred with other capsid inhibitors, thus far none have appeared to be associated with meaningful declines in HBsAg,” said Dr.
Dr. Picchio added, “To date, all capsid inhibitor studies done in healthy subjects have been limited to a maximum of 14 days of dosing. In the second half of 2019 we intend to initiate a healthy subjects study testing 28 days of dosing. An absence of flares in this study, if observed, should help us better understand the nature of the ALT flares observed in the CHB cohorts.”
A detailed analysis of these Phase 1a/1b preliminary results, including a complete characterization of the ALT flare cases and preliminary results from the new 28 day study in healthy subjects, will be submitted for presentation at a scientific meeting later this year.
About the AB-506 Phase 1a/1b Clinical Trial
AB-506-001 is a double-blind, randomized, placebo controlled, single and multiple dose clinical trial evaluating the safety, tolerability and pharmacokinetics of AB-506, an oral class II capsid inhibitor, in healthy subjects and HBV-DNA positive subjects with chronic HBV infection. The healthy subject portion of the clinical trial and two cohorts of CHB subjects have been completed. The healthy subject portion consisted of a single ascending dose (SAD) part in which subjects were randomized 6:2 (active: placebo), n=21, to receive AB-506 doses ranging from 30-1000 mg, including investigation of food effect, and a multiple dose (MD) part in which subjects (randomized 10:2, n=12) received 400 mg of AB-506 once daily for 10 days. The third part of the study is enrolling HBV DNA+, HBeAg-positive or -negative CHB subjects (randomized 10:2; n=12 per cohort) at different doses of AB-506, with or without a nucleoside analog, once daily for 28 days. Dosing of additional cohorts is planned.
AB-506 is an oral HBV capsid inhibitor. HBV core protein assembles into a capsid structure, which is required for viral replication. The current standard-of-care therapy for HBV, primarily nucleoside analogues that work by stopping the viral polymerase, significantly reduce virus replication, but not completely. Capsid inhibitors inhibit replication by preventing the assembly of functional viral capsids and also by inhibiting the uncoating step of the viral life cycle thus reducing the formation of new covalently closed circular DNA (cccDNA), the viral reservoir which resides in the cell nucleus.
Conference Call Today
Arbutus will hold a conference call and webcast today,
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 8499742.
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 safety and efficacy of AB-506; the timing and expectations regarding Arbutus’ ongoing clinical trials; the potential for AB-506 to contribute to the inhibition of HBV replication as part of a combination regime; and the potential for our drug candidates to improve upon the standard of care and contribute to a curative combination regime.
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 and clinical trials, and the usefulness of the data; the availability and timing of data from clinical trials; and the adequacy of any clinical models. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
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 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; the possibility that interim data of the Phase 1a/1b clinical trial are not indicative of final data from all patients in the clinical trial and final data may not be positive with regard to the safety or efficacy of AB-506; 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.
A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and periodic and continuous 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.
Source: Arbutus Biopharma Corporation