SOUTH SAN FRANCISCO, CA, USA I and WARMINSTER, PA, USA I February 26, 2021 I Assembly Biosciences, Inc. (Nasdaq: ASMB) and Arbutus Biopharma Corporation (Nasdaq: ABUS) today announced the initiation of a Phase 2 clinical trial of Assembly Bio’s investigational hepatitis B virus (HBV) core inhibitor candidate, also known as a capsid inhibitor, vebicorvir (VBR), in combination with Arbutus’ proprietary GalNAc delivered RNAi therapeutic candidate, AB-729, and standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy for the treatment of patients with chronic HBV infection. The companies announced a clinical collaboration agreement in August 2020.
The randomized, multi-center, open-label Phase 2 clinical trial will evaluate the safety, pharmacokinetics, and antiviral activity of the triple combination of VBR, AB-729 and an NrtI compared to the double combinations of VBR with an NrtI and AB-729 with an NrtI. Approximately 60 virologically-suppressed patients with HBeAg negative chronic HBV are expected to be enrolled across these three treatment arms. Patients will be dosed for 48 weeks with VBR 300 mg orally once daily and AB-729 60 mg subcutaneously every 8 weeks, with a 48-week follow-up period. The primary objective of the trial is to evaluate the safety and tolerability of the triple combination, while secondary objectives of the trial include evaluating the effect of the triple combination in reducing HBV viral biomarkers such as HBV DNA, HBV pgRNA and HBsAg. Additional cohorts may be added in the future to evaluate other patient populations and/or combinations.
“We are excited to move forward with our collaborators in this proof-of-concept Phase 2 clinical trial designed to evaluate multiple complementary mechanisms of action. Importantly, this trial supports our long-standing belief that multi-drug combinations will be needed to provide patients with chronic hepatitis B a much needed and durable functional cure,” stated Gaston Picchio, PhD, Chief Development Officer at Arbutus. “We believe reducing HBsAg will be a key component of future HBV curative therapies. AB-729, Arbutus’ lead HBV asset, has demonstrated competitive HBsAg reductions and a favorable safety and tolerability profile in an ongoing Phase 1b clinical trial, and we are gratified to have it progress in this combination trial.”
“Our lead core inhibitor candidate, vebicorvir, in combination with standard-of-care NrtI therapy, demonstrates enhanced antiviral activity with a favorable safety profile fueling our belief that core inhibitors will become a central component of finite and curative therapies for patients with HBV,” said Luisa Stamm, MD, PhD, Chief Medical Officer at Assembly Bio. “We also believe that exploring multi-drug combinations with complementary mechanisms of action could increase response rates. We look forward to exploring the promise of combination therapies in our work with Arbutus.”
About Vebicorvir, Assembly’s Lead HBV Core Inhibitor
Assembly Bio’s HBV portfolio includes three clinical-stage small molecule candidates, all of which are HBV core inhibitors that target multiple steps of the HBV replication cycle. In Phase 2 clinical trials, first-generation core inhibitor vebicorvir (VBR) administered with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy demonstrated a favorable safety profile and led to greater viral suppression of both HBV DNA and HBV pgRNA than NrtI therapy alone. VBR is advancing in multiple Phase 2 combination studies.
About Arbutus’ AB-729
AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Based upon clinical data generated thus far in an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 has demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.
About HBV
Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that afflicts approximately 270 million people worldwide with up to 90 million people in China, as estimated by the World Health Organization. HBV is a global epidemic that affects more people than hepatitis C virus (HCV) and HIV infection combined—with a higher morbidity and mortality rate. HBV is a leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes.
The current standard of care for patients with chronic HBV infection is life-long suppressive treatment with medications that reduce, but do not eliminate, the virus, resulting in very low cure rates. There is a significant unmet need for new therapies to treat HBV.
About Assembly Biosciences
Assembly Bio is a clinical-stage biotechnology company committed to bringing finite and curative therapies to the 270 million people living with hepatitis B virus (HBV) worldwide. A pioneer in the development of a new class of potent, oral core inhibitor drug candidates, Assembly Bio’s approach aims to break the complex viral replication cycle of HBV to free patients from a lifetime of therapy. Assembly Bio’s strategy toward cure includes a leading portfolio of more potent, next-generation core inhibitors, proof-of-concept combination studies and a research program focused on the discovery of novel HBV targets. For more information, visit assemblybio.com.
About Arbutus
Arbutus Biopharma Corporation is a publicly traded (Nasdaq: ABUS) biopharmaceutical company primarily dedicated to discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, visit www.arbutusbio.com.
SOURCE: Assembly Biosciences
Post Views: 29
SOUTH SAN FRANCISCO, CA, USA I and WARMINSTER, PA, USA I February 26, 2021 I Assembly Biosciences, Inc. (Nasdaq: ASMB) and Arbutus Biopharma Corporation (Nasdaq: ABUS) today announced the initiation of a Phase 2 clinical trial of Assembly Bio’s investigational hepatitis B virus (HBV) core inhibitor candidate, also known as a capsid inhibitor, vebicorvir (VBR), in combination with Arbutus’ proprietary GalNAc delivered RNAi therapeutic candidate, AB-729, and standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy for the treatment of patients with chronic HBV infection. The companies announced a clinical collaboration agreement in August 2020.
The randomized, multi-center, open-label Phase 2 clinical trial will evaluate the safety, pharmacokinetics, and antiviral activity of the triple combination of VBR, AB-729 and an NrtI compared to the double combinations of VBR with an NrtI and AB-729 with an NrtI. Approximately 60 virologically-suppressed patients with HBeAg negative chronic HBV are expected to be enrolled across these three treatment arms. Patients will be dosed for 48 weeks with VBR 300 mg orally once daily and AB-729 60 mg subcutaneously every 8 weeks, with a 48-week follow-up period. The primary objective of the trial is to evaluate the safety and tolerability of the triple combination, while secondary objectives of the trial include evaluating the effect of the triple combination in reducing HBV viral biomarkers such as HBV DNA, HBV pgRNA and HBsAg. Additional cohorts may be added in the future to evaluate other patient populations and/or combinations.
“We are excited to move forward with our collaborators in this proof-of-concept Phase 2 clinical trial designed to evaluate multiple complementary mechanisms of action. Importantly, this trial supports our long-standing belief that multi-drug combinations will be needed to provide patients with chronic hepatitis B a much needed and durable functional cure,” stated Gaston Picchio, PhD, Chief Development Officer at Arbutus. “We believe reducing HBsAg will be a key component of future HBV curative therapies. AB-729, Arbutus’ lead HBV asset, has demonstrated competitive HBsAg reductions and a favorable safety and tolerability profile in an ongoing Phase 1b clinical trial, and we are gratified to have it progress in this combination trial.”
“Our lead core inhibitor candidate, vebicorvir, in combination with standard-of-care NrtI therapy, demonstrates enhanced antiviral activity with a favorable safety profile fueling our belief that core inhibitors will become a central component of finite and curative therapies for patients with HBV,” said Luisa Stamm, MD, PhD, Chief Medical Officer at Assembly Bio. “We also believe that exploring multi-drug combinations with complementary mechanisms of action could increase response rates. We look forward to exploring the promise of combination therapies in our work with Arbutus.”
About Vebicorvir, Assembly’s Lead HBV Core Inhibitor
Assembly Bio’s HBV portfolio includes three clinical-stage small molecule candidates, all of which are HBV core inhibitors that target multiple steps of the HBV replication cycle. In Phase 2 clinical trials, first-generation core inhibitor vebicorvir (VBR) administered with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy demonstrated a favorable safety profile and led to greater viral suppression of both HBV DNA and HBV pgRNA than NrtI therapy alone. VBR is advancing in multiple Phase 2 combination studies.
About Arbutus’ AB-729
AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Based upon clinical data generated thus far in an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 has demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.
About HBV
Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that afflicts approximately 270 million people worldwide with up to 90 million people in China, as estimated by the World Health Organization. HBV is a global epidemic that affects more people than hepatitis C virus (HCV) and HIV infection combined—with a higher morbidity and mortality rate. HBV is a leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes.
The current standard of care for patients with chronic HBV infection is life-long suppressive treatment with medications that reduce, but do not eliminate, the virus, resulting in very low cure rates. There is a significant unmet need for new therapies to treat HBV.
About Assembly Biosciences
Assembly Bio is a clinical-stage biotechnology company committed to bringing finite and curative therapies to the 270 million people living with hepatitis B virus (HBV) worldwide. A pioneer in the development of a new class of potent, oral core inhibitor drug candidates, Assembly Bio’s approach aims to break the complex viral replication cycle of HBV to free patients from a lifetime of therapy. Assembly Bio’s strategy toward cure includes a leading portfolio of more potent, next-generation core inhibitors, proof-of-concept combination studies and a research program focused on the discovery of novel HBV targets. For more information, visit assemblybio.com.
About Arbutus
Arbutus Biopharma Corporation is a publicly traded (Nasdaq: ABUS) biopharmaceutical company primarily dedicated to discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, visit www.arbutusbio.com.
SOURCE: Assembly Biosciences
Post Views: 29
