Arbutus BioPharma Corp (NASDAQ:ABUS) has announced additional results from the on-going Phase 1a/1b clinical study with AB-729, the company’s novel GaINAc delivered RNAi compound.
Arbutus releases additional AB-729 study results
The additional data the company released builds on the presentation titled, “safety and pharmacodynamics of the GaINAc-siRNA AB-729 in subjects with chronic hepatitis B infection.” The company presented the results at the Liver Meeting Digital Experience™, The American Association for the Study of Liver Diseases (AASLD) conference on November 15, 2020. The new data include HBsAg data for the 60 mg multi-dose cohort at week 20 as well as initial AB-729 90mg single dose cohort results of HBV DNA positive subjects.
Arbutus CEO and President William Collier said that through 2020 the company reported data demonstrating strong safety and efficacy of AB-729 in several patient cohorts. He said that the data supports the expansion of AB-7729 into phase 2a clinical trials in 2021 and also supports confidence in the potential of AB-729 becoming an important future combination regimens treatment for chronic hepatitis B treatment. Collier explained that the additional positive data and the data presented at AASLD are encouraging to support AB-729’s therapeutic value.
AB-729 has the potential of dosing after 8 weeks instead of four
The company’s Chief Development Officer Gaston Picchio said that the mean HBsAg witnessed at week 16 suggests that AB-729 has the potential of offering patients the alternative of dosing after every eight weeks instead of four weeks. He said that more dosing will enable the company to confirm the finding.
Most importantly, AB-729’s safety has been unremarkable and Picchio said that there haven’t been any cases of Grade 3/4 AEs or dosing-related discontinuation to date. However, in Cohort F, two participants had asymptomatic ALT elevations that are not AEs. Also, a subject with Grade 1 ALT elevations before study enrolment showed intermittent Grade 2 elevations with another subject reporting transient Grade 1 elevation which eased as they continued with treatment. The most important finding is that AB-729 dosing can be after 8 or 12 weeks.
