Clinical-stage biopharmaceutical company Arbutus Biopharma Corp. (ABUS:NASDAQ), which is focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, yesterday announced "positive follow-up data from a Phase 1a/1b clinical trial (AB-729-001) in chronic HBV subjects on nucleos(t)ide therapy who received a single subcutaneous injection of 60 mg of AB-729, a proprietary GalNAc delivered RNAi compound."
The company's President and CEO William Collier commented, "These new data further demonstrate the robust activity of AB-729. At week 12, the 60 mg single-dose achieved equivalent reductions in HBsAg as the 180 mg single-dose. We are currently dosing chronic HBV subjects in a multi-dose cohort with 60 mg of AB-729. These data keep us on track for achieving our goal of delivering a combination therapy that includes HBsAg reduction in chronic hepatitis B subjects."
The firm's Chief Development Officer Dr. Gaston Picchio remarked, "Importantly, throughout the 12 week period, not only does AB-729 demonstrate robust HBsAg reduction, it does so while remaining generally safe and well tolerated with no abnormal transaminase values in any of the six subjects...We are impressed by both the magnitude and continuous reduction in HBsAg achieved with a single 60 mg dose. We believe that these features could provide a competitive advantage with a low dose and reduced frequency of injections...As we previously announced we are also exploring an additional 90 mg single-dose cohort. We expect data from both the 60 mg multi-dose cohorts as well as week 12 90 mg single-dose data in H2/20."
The company explained that AB-729-001 is an ongoing first-in-human clinical trial consisting of three parts. Part 1 included three cohorts of randomized healthy subjects, Part 2 enlisted six non-cirrhotic, HBeAg positive or negative, chronic HBV subjects, and Part 3 is studying chronic HBV DNA negative and HBV DNA positive subjects who will receive multi-doses of AB-729 for up to six months.
The company stated on its website that hepatitis B is a potentially life-threatening liver infection caused by HBV, which can cause chronic infection that leads to a higher risk of death from cirrhosis and liver cancer. The firm additionally indicated that the World Health Organization estimates that chronic HBV infection affects 250 million people worldwide.
The firm stated that the COVID-19 situation has resulted in significant disruptions to many businesses and that measures closing businesses and requiring people to stay in their homes raises uncertainty regarding the ability to travel to hospitals in order to participate in clinical trials. The firm stated that "while we have been able to progress with our clinical and pre-clinical activities to date, it is not possible to predict if the COVID-19 pandemic will negatively impact our plans and timelines in the future."
Arbutus Biopharma is a biopharmaceutical company based in Warminster, Penn. The firm is engaged in discovering, developing and commercializing a cure for people with chronic hepatitis B (HBV) infection. The company stated that it is investigating several drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection.
Arbutus Biopharma has a market capitalization of around $129 million with approximately 68.96 million shares outstanding. ABUS shares opened nearly 44% higher today at $2.69 (+$0.82, +43.85%) over yesterday's $1.87 closing price. The stock has traded today between $2.28 and $2.69 per share and is currently trading at $2.38 (+$0.51, +27.27%).[NLINSERT]
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