The US FDA Gives Arbutus Biopharma Corporation (NASDAQ: ABUS) Authority to Advance with an Investigational New Drug Application (IND) for AB-729

About 27 million people worldwide could be suffering from chronic HBV infection, and only 4.5 million are on treatment. Today’s treatment options include nucleos and pegylated interferon regimens. Unfortunately, only about 5% or less of these patients are cured by these current treatment options, while the rest have to take NA therapy daily and perhaps for the rest of their lives. However, Arbutus Biopharma Corporation (NASDAQ: ABUS) is likely to change this situation. Thanks to a recent authorization of its Investigational New Drug (IND) application for AB-729 by the US FDA.

The Phase 2a clinical trial is evaluating the safety and efficacy of an RNA interference (RNAi) therapeutic in combination with ongoing nucleos (t)ide analog (NA) therapy. In addition, the trial will also allow the investigation of short courses of Peg-IFN. The Phase 1a/1b clinical trial of AB-729 already demonstrated favorable safety and tolerability with meaningful hepatitis B surface antigen reductions.

“We are gratified that our IND submission for AB-729, in combination with Peg-IFN, in subjects… has been deemed safe to proceed… could contribute to achieving a functional cure in HBeAg negative chronic hepatitis B subjects.” Chief Development Officer at Arbutus, Gaston Picchio, stated.

The Objective is to Establish Value for Cancer Patients

A significant unmet medical need remains for HBV patients and their healthcare providers. Hence, according to the company’s CEO William Collier, the proof-of-concept Phase 2a clinical trial is one of Arbutus’ milestones this quarter. In addition, it defines the company’s focus in discovering, developing, and commercializing a cure for people with chronic hepatitis B virus. And based on the positive clinical results, it is clear that AB-729 is likely to value CHB patients as a durable, functional cure.

Meanwhile, Arbutus has also taken up a new project; drug discovery and development for treating coronaviruses. This is in addition to advancing multiple product candidates with different levels of potential and mechanisms of action. The good news is that there is a compelling market for the company’s portfolio.

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