Single Dose Data Demonstrate Significant Reduction in Serum HBsAg
Additive Reductions in Serum HBsAg Observed with Repeat Dosing over 3 Months
5 of 6 Patients in Cohort 1 Had Serum HBsAg Reductions of Greater Than 0.5 log10 After 3 Doses
Additional Multi-Dose ARB-1467 Data Expected in 4Q16
Company to Host Conference Call Today at 5 pm ET to Discuss Results
VANCOUVER, Canada and DOYLESTOWN, PA, USA I September 29, 2016 I Arbutus Biopharma Corporation (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) |
| Cohort |
N |
ARB-1467
(mg/kg) |
Meana |
Mean Maximumb |
Maximumc |
Meana |
Mean Maximumb |
Maximumc |
| 1 |
6 |
0.2 |
-0.3 |
-0.4 |
-1.0 |
-0.6 |
-0.7 |
-1.3 |
| 2 |
6 |
0.4 |
-0.2 |
-0.3 |
-0.8 |
NA |
NA |
NA |
| Placebo |
4d |
|
0.0 |
0.0 |
-0.1 |
0.0 |
0.0 |
-0.1 |
| |
| 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.”
ARB-1467 Phase 2 Trial Design
The Phase II trial is a multi-dose study in chronic HBV patients who are also receiving stable nucleot(s)ide analog therapy. The trial consists of three cohorts, each enrolling eight subjects; six receiving three monthly doses of ARB-1467, and two receiving placebo. The first two cohorts include HBeAg- patients, followed by a third cohort in HBeAg+ patients.
About ARB-1467
Arbutus’ RNAi candidate ARB-1467 comprises three RNAi triggers that target all four HBV transcripts, and has been shown in preclinical studies to reduce all viral antigen levels as well as cccDNA and HBV DNA. ARB-1467 utilizes Arbutus’ proprietary lipid nanoparticle (LNP) platform, a clinically validated delivery technology which has been tested in hundreds of patients.
Conference Call Today
Arbutus will hold a conference call and webcast today, September 29, 2016, at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to provide interim results from the ongoing ARB-1467 Phase II clinical trial. A live webcast of the call can be accessed through the Investor section of Arbutus’ website at www.arbutusbio.com. Or, alternatively, to access the conference call, please dial 1-914-495-8556 or 1-866-393-1607.
An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling 1-404-537-3406 or 1-855-859-2056 and referencing conference ID 91182747.
About Arbutus
Arbutus Biopharma Corporation is a biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic HBV infection. Arbutus is headquartered in Vancouver, BC, Canada with offices in Doylestown, PA, USA. For more information, visit www.arbutusbio.com.
SOURCE: Arbutus Biopharma
Post Views: 101
Single Dose Data Demonstrate Significant Reduction in Serum HBsAg
Additive Reductions in Serum HBsAg Observed with Repeat Dosing over 3 Months
5 of 6 Patients in Cohort 1 Had Serum HBsAg Reductions of Greater Than 0.5 log10 After 3 Doses
Additional Multi-Dose ARB-1467 Data Expected in 4Q16
Company to Host Conference Call Today at 5 pm ET to Discuss Results
VANCOUVER, Canada and DOYLESTOWN, PA, USA I September 29, 2016 I Arbutus Biopharma Corporation (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) |
| Cohort |
N |
ARB-1467
(mg/kg) |
Meana |
Mean Maximumb |
Maximumc |
Meana |
Mean Maximumb |
Maximumc |
| 1 |
6 |
0.2 |
-0.3 |
-0.4 |
-1.0 |
-0.6 |
-0.7 |
-1.3 |
| 2 |
6 |
0.4 |
-0.2 |
-0.3 |
-0.8 |
NA |
NA |
NA |
| Placebo |
4d |
|
0.0 |
0.0 |
-0.1 |
0.0 |
0.0 |
-0.1 |
| |
| 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.”
ARB-1467 Phase 2 Trial Design
The Phase II trial is a multi-dose study in chronic HBV patients who are also receiving stable nucleot(s)ide analog therapy. The trial consists of three cohorts, each enrolling eight subjects; six receiving three monthly doses of ARB-1467, and two receiving placebo. The first two cohorts include HBeAg- patients, followed by a third cohort in HBeAg+ patients.
About ARB-1467
Arbutus’ RNAi candidate ARB-1467 comprises three RNAi triggers that target all four HBV transcripts, and has been shown in preclinical studies to reduce all viral antigen levels as well as cccDNA and HBV DNA. ARB-1467 utilizes Arbutus’ proprietary lipid nanoparticle (LNP) platform, a clinically validated delivery technology which has been tested in hundreds of patients.
Conference Call Today
Arbutus will hold a conference call and webcast today, September 29, 2016, at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to provide interim results from the ongoing ARB-1467 Phase II clinical trial. A live webcast of the call can be accessed through the Investor section of Arbutus’ website at www.arbutusbio.com. Or, alternatively, to access the conference call, please dial 1-914-495-8556 or 1-866-393-1607.
An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling 1-404-537-3406 or 1-855-859-2056 and referencing conference ID 91182747.
About Arbutus
Arbutus Biopharma Corporation is a biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic HBV infection. Arbutus is headquartered in Vancouver, BC, Canada with offices in Doylestown, PA, USA. For more information, visit www.arbutusbio.com.
SOURCE: Arbutus Biopharma
Post Views: 101
