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Arbutus receives regulatory clearance to initiate Phase 1a/1b Clinical Trial of AB-729 | ||
By: Nasdaq / GlobeNewswire - 20 Jun 2019 | Back to overview list |
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- AB-729 is a subcutaneously-administered RNAi agent targeting HBV replication and HBsAg antigen production - Supports corporate objective to combine AB-729 with AB-506, Arbutus’ proprietary oral capsid inhibitor WARMINSTER, Pa., June 20, 2019 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, today announced it has received regulatory clearance to initiate a Phase 1a/1b clinical trial of AB-729, Arbutus’ subcutaneously-administered RNA interference (RNAi) agent. AB-729 employs a single RNAi trigger that has been shown in preclinical models to span all HBV transcripts, reduce all viral antigens, including hepatitis B surface antigen (HBsAg) expression, and inhibit HBV replication. This RNAi agent uses Arbutus’ proprietary covalently conjugated N-acetylgalactosamine (GalNAc) hepatocyte targeting technology which is expected to allow for once-a-month dosing. As previously announced on May 3rd, a regulatory authority requested that Arbutus complete its ongoing 3- and 6-month toxicology studies before commencing the single ascending portion of the Phase 1a/1b clinical trial of AB-729. Based on further interaction with the regulatory authority, a revised protocol was submitted and Arbutus has received clearance to begin the Phase 1a/1b clinical trial. Dr. Gaston Picchio, Arbutus’s Chief Development Officer, said, “The Phase 1a/1b clinical trial of AB-729 is expected to initiate shortly and will initially be evaluated in healthy volunteers followed by chronic hepatitis B patients in single ascending dose cohorts.” Dr. Picchio, added, “We believe the combination of AB-729 and AB-506, our oral capsid inhibitor, has the potential to result in more profound inhibition of HBV replication in conjunction with a reduction in HBsAg levels thus enabling a reawakening of the patient’s immune system. We also believe that these combined effects should lead to significantly higher rates of sustained HBsAg loss than the current standard of care after a yet-to-be-established finite dosing period.” About the AB-729 Phase 1a/1b Clinical Trial About AB-729 About AB-506 About Arbutus Forward-Looking Statements and Information With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the timely receipt of expected payments; the effectiveness and timeliness of preclinical 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. 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 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 and Quarterly Reports on Form 10-Q and Arbutus' 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. Contact Information Investors Media |
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Copyright 2019 Nasdaq / GlobeNewswire | Back to overview list |