Arbutus Biopharma Corporation (Nasdaq: ABUS) has taken a major step forward in its mission to provide a potential functional cure for hepatitis B virus (HBV) patients, announcing that the first subject has been dosed in its Phase 1 clinical trial of AB-161, an oral RNA destabilizer. The trial is designed to assess the safety, tolerability, and pharmacokinetics of the treatment, which could be used in an all-oral combination regimen to help provide a functional cure for HBV sufferers.
Arbutus Biopharma is thrilled to announce the commencement of Phase 1 clinical trials for its new HBV treatment, AB-161. Designed to reduce HBsAg levels and inhibit viral replication, AB-161 selectively targets essential host proteins to stabilize HBV RNA from degradation. We remain dedicated to developing a functional cure for chronic HBV and look forward to sharing the initial Phase 1 results in the second half of 2023.
In this exciting Phase 1 double-blind, randomized, placebo-controlled clinical trial, we will investigate the safety, tolerability, and pharmacokinetics of oral administration of AB-161 in healthy subjects. Ten unique cohorts of 8 active and 2 placebo subjects will be given single doses of AB-161, and safety assessments will be done continuously and after day 7. If the results are acceptable, a new cohort will receive an escalated dose of AB-161. To further assess the food effect, a dose close to the anticipated therapeutic dose in chronic HBV patients will be administered. Join us in this groundbreaking study to discover more about the potential of AB-161!
We are eagerly anticipating the Phase 1 single-ascending dose clinical trial results in healthy subjects, which are expected to arrive in the second half of 2023. This data is sure to provide valuable insights into the safety and efficacy of the treatment in question.
AB-161 is the newest innovation in oral small molecule RNA destabilizers, designed to effectively target the liver. Through its mechanism of action, AB-161 selectively degrades HBV RNAs and reduces HBsAg levels, thereby inhibiting viral replication. This exciting advancement offers a convenient, all-oral treatment regimen for those suffering from cHBV, making it an essential part of the fight against this disease.
Hepatitis B is a potentially deadly liver infection caused by the hepatitis B virus (HBV). Statistically, it is estimated that over 290 million people worldwide suffer from chronic HBV infection, with approximately 2.4 million people in the United States alone. Sadly, this chronic infection can lead to a greater risk of death from cirrhosis and liver cancer, with an estimated 820,000 people dying every year due to complications related to chronic HBV infection. Fortunately, there are effective vaccines and treatments available to reduce the risk of severe complications from this virus.
Arbutus Biopharma Corporation is an innovative clinical-stage biopharmaceutical company with a mission to develop novel therapeutics to target specific viral diseases. Our main focus areas include Hepatitis B virus (HBV), SARS-CoV-2, and other coronaviruses. Our lead compound, AB-729, is the only RNAi therapeutic with evidence of immune re-awakening and is currently being evaluated in multiple phase 2 clinical trials. We are also exploring the use of our internal PD-L1 portfolio in oncology applications. Additionally, we have an ongoing drug discovery and development program aimed at identifying novel, orally active agents for treating coronaviruses, such as SARS-CoV-2, with the goal of improving treatment outcomes.