{"id":381420,"date":"2020-11-16T07:03:19","date_gmt":"2020-11-16T12:03:19","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=381420"},"modified":"2020-11-16T07:03:19","modified_gmt":"2020-11-16T12:03:19","slug":"arbutus-announces-additional-robust-hbsag-decline-data-with-ab-729-in-chronic-hepatitis-b-subjects","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/arbutus-announces-additional-robust-hbsag-decline-data-with-ab-729-in-chronic-hepatitis-b-subjects\/","title":{"rendered":"Arbutus Announces Additional Robust HBsAg Decline Data with AB-729 in Chronic Hepatitis B Subjects"},"content":{"rendered":"
\n

\n Data released today expands on <\/strong>
\n November 15, 2020 <\/strong>
\n AASLD presentation<\/strong>
\n \n <\/p>\n

\n Repeat dosing of 60 mg AB-729 every 4 weeks resulted in<\/strong>
\n robust and continuous<\/strong>
\n mean<\/strong>
\n declines in <\/strong>
\n HBsAg decline at week 20 (-1.71 log10IU\/mL<\/strong>
\n , N=7<\/strong>
\n )<\/strong>
\n and<\/strong>
\n f<\/strong>
\n urther reductions continued beyond week 20 (-1.84 log10 IU\/mL, N=3)<\/strong><\/p>\n

In HBV DNA positive subjects, a single 90 mg AB-729 dose resulted in robust<\/strong>
\n mean<\/strong>
\n declines in <\/strong>
\n HBsAg (<\/strong>
\n -1.02 log10 IU\/mL<\/strong>
\n )<\/strong>
\n , <\/strong>
\n HBV DNA (<\/strong>
\n -1.5<\/strong>
\n 3<\/strong>
\n log10 IU\/mL<\/strong>
\n )<\/strong>
\n , HBV RNA and <\/strong>
\n HBcrAg<\/strong>
\n at week 12<\/strong><\/p>\n

Results <\/strong>
\n support advanc<\/strong>
\n ement in<\/strong>
\n to Phase 2 combination <\/strong>
\n clinical trials<\/strong>
\n with AB-729 dosing <\/strong>
\n as infrequently as <\/strong>
\n every 8 or 12 weeks<\/strong>\n <\/p>\n

\n Conference Call and Webcast Scheduled <\/strong>
\n Today at 8:00 am ET<\/strong>\n <\/p>\n

WARMINSTER, Pa., Nov. 16, 2020 (GLOBE NEWSWIRE) — \u00a0Arbutus Biopharma Corporation\u00a0(Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection as well as therapies to treat coronaviruses (including COVID-19), today announced additional clinical data from an ongoing Phase 1a\/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound.<\/p>\n

The new data described today expands on the presentation entitled Safety and pharmacodynamics of the <\/em>GalNAc<\/em>-siRNA AB-729 in subjects with chronic hepatitis B infection, <\/em>recorded on October 14, 2020 and presented on November 15, 2020 by Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., from the University of Hong Kong at The Liver Meeting Digital ExperienceTM<\/sup>, The American Association for the Study of Liver Diseases (AASLD) Meeting.<\/p>\n

The new data summarized below include HBsAg data for the complete 60 mg every 4 weeks multi-dose cohort (N=7) at week 20, and the first results for the AB-729 90 mg single-dose cohort of HBV DNA positive subjects (N=5). <\/p>\n

William Collier, President and Chief Executive Officer of Arbutus, stated, \u201cThe positive data described today, together with the strong safety and efficacy results presented by Professor Yuen at AASLD yesterday, are encouraging and continue to support our confidence in the therapeutic value of AB-729 as we plan to move into Phase 2 clinical trials.\u201d<\/p>\n

\n Summary of new data<\/strong>\n <\/p>\n

\n Repeat dosing of AB-729 60 mg every 4 weeks results in continuous <\/strong>
\n declines in <\/strong>
\n mean <\/strong>
\n HBsAg through week 20<\/strong>
\n (Cohort E)<\/strong>\n <\/p>\n\n\n\n
\u00a0<\/td>\n\n Mean (SE) Week 16<\/strong>
\n
\n N=7<\/strong>\n <\/td>\n		\n Mean (SE) Week 20<\/strong>
\n
\n N=7<\/strong>\n <\/td>\n		\n Mean (SE) Week 24<\/strong>
\n
\n N=3<\/strong>\n <\/td>\n<\/tr>\n
\n \u00a0\u0394log10 HBsAg (IU\/mL)<\/strong>\n <\/td>\n\n -1.44 (0.18)<\/strong>\n <\/td>\n\n -1.71 (0.18)<\/strong>\n <\/td>\n\n -1.84 (0.10)<\/strong>\n <\/td>\n<\/tr>\n<\/table>\n

Dr. Gaston Picchio, Chief Development Officer at Arbutus stated, \u201cFurther follow up of the 60 mg every 4 weeks multi-dose cohort confirmed continuous reductions in mean HBsAg at week 20 (N=7), and in a subset of subjects (N=3) beyond this time point, while being generally safe and well tolerated. Additionally, the mean HBsAg declines and slopes of declines are similar between single doses and repeat doses of AB-729 up to week 12. Importantly, this suggests that dosing AB-729 as frequently as every 4 weeks may not be necessary, and that AB-729 has the potential to be dosed every 8 weeks or even every 12 weeks. This dosing strategy is being investigated in other cohorts of the trial with results from the 60 mg every 8 week cohort expected before the end of 2020.\u201d<\/p>\n

AB-729 90 mg single-dose <\/strong>reduces <\/strong>HBsAg and HBV DNA in <\/strong>HBV DNA positive<\/strong> chronic Hepatitis B (CHB)<\/strong>subjects <\/strong>with mean <\/strong>HBsAg declin<\/strong>es<\/strong>similar to <\/strong>those seen in <\/strong>HBV DNA negative<\/strong>subjects<\/strong> (Cohort D)<\/strong><\/p>\n\n\n\n\n
\n \u00a0<\/strong>\n <\/td>\n\n Mean (SE) Week 12<\/strong>
\n
\n N=5<\/strong>\n <\/td>\n		\u00a0<\/td>\n<\/tr>\n
\n \u00a0\u0394<\/strong>
\n log10 HBsAg (IU\/mL)<\/strong>\n <\/td>\n		\n -1.02 (0.13)<\/strong>\n <\/td>\n\u00a0<\/td>\n<\/tr>\n
\n \u00a0\u0394log10 HBV DNA (IU\/mL)<\/strong>\n <\/td>\n\n -1.53 (0.24)<\/strong>\n <\/td>\n\u00a0<\/td>\n<\/tr>\n<\/table>\n

Dr. Picchio added, \u201cIt is also encouraging to observe that a single 90 mg dose of AB-729 is capable of reducing HBsAg in HBV DNA positive subjects to the same extent achieved in other single-dose HBV DNA negative cohorts. Further, a single 90 mg AB-729 dose substantially reduced HBV DNA as well as HBV RNA and HBcrAg.\u201d<\/p>\n

\n AB-729 was safe and well tolerated after single and rep<\/strong>
\n eat doses<\/strong>\n <\/p>\n