Arbutus Biopharma (ABUS) Announces Results from Phase II Trial of ARB-1467 for Chronic HBV Infection

September 29, 2016 4:02 PM EDT
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Arbutus Biopharma Corporation (Nasdaq: ABUS), an industry-leading hepatitis B virus (HBV) therapeutic solutions company, today reported interim results from the first two cohorts of the ongoing ARB-1467 Phase II multi-dose clinical trial in chronically infected HBV patients. The first two cohorts enrolled patients with hepatitis B e-antigen (HBeAg) negative chronic HBV infection. At this time, serum HBsAg data are available following single doses for both Cohort 1 and Cohort 2 and following multiple doses for Cohort 1.

Single dose ARB-1467 results for Cohorts 1 and 2 demonstrate significant reductions in serum HBsAg levels. Importantly, multiple dose results from Cohort 1 show a step-wise, additive reduction in serum HBsAg. These multiple dose results are the first of their kind for an RNAi product candidate in patients with chronic HBV infection. Treatment with ARB-1467 has been generally well tolerated to date.

Single Dose HBsAg Reduction(log10 IU/mL)Multiple Dose HBsAg Reduction(log10 IU/mL)
CohortN ARB-1467 (mg/kg) Meana Mean Maximumb Maximumc Meana Mean Maximumb Maximumc
Placebo 4d 0.00.0-
aThe mean serum HBsAg reduction is the nadir value of the arithmetic mean of all values observed at each time point.
bThe mean maximum HBsAg reduction is the mean of each patient’s maximum reduction in serum HBsAg.
cMaximum HBsAg reduction is the best single reduction among all patients in a cohort.
dSingle dose placebo results are based on four subjects (two from each cohort). Multiple dose placebo results are based on the two placebo subjects in Cohort 1.

“The interim ARB-1467 data demonstrate significant serum HBsAg reduction following the first dose, which is enhanced with repeat dosing. This is a very important finding because it suggests that even greater reductions in serum HBsAg levels may be observed with continued dosing of ARB-1467,” said Dr. Douglas T. Dieterich, Professor of Medicine in the Division of Liver Disease at Icahn School of Medicine at Mount Sinai Medical Center. “These exciting data demonstrate the antiviral effect of ARB-1467 and the potential to include this agent as a component of a combination therapy regimen for the treatment of chronic HBV infection.”

“We are excited about these HBV efficacy data from our ongoing ARB-1467 Phase II trial demonstrating substantial reductions in serum HBsAg, which is an important first step towards one day curing chronic HBV infection. We believe that further study of ARB-1467 will help determine the optimal protocol to produce maximal reductions in serum HBsAg,” said Dr. Mark J. Murray, Arbutus’ President and CEO. “We plan to release additional multi-dose data later this year. We believe that ultimately curing HBV will require combination therapy and we are developing a portfolio of HBV assets with complementary mechanisms of action to accomplish this goal.”

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