Arbutus Biopharma Corporation (Nasdaq: ABUS) has announced promising data from its IM-PROVE I Phase 2a clinical trial, indicating significant progress in the treatment of chronic hepatitis B virus (cHBV). The trial results, presented at The Liver Meeting® 2024 by the American Association for the Study of Liver Diseases, highlight the potential of combining Arbutus’s RNAi therapeutic, imdusiran, with pegylated interferon alfa-2α (IFN) and ongoing nucleos(t)ide analogue (NA) therapy.
Key Findings from the IM-PROVE I Trial
The IM-PROVE I trial demonstrated that six doses of imdusiran combined with 24 weeks of IFN led to a functional cure in 50% of HBeAg-negative patients who had baseline hepatitis B surface antigen (HBsAg) levels below 1000 IU/mL. Overall, the trial achieved a 25% functional cure rate among all participants. A functional cure is defined as sustained HBsAg loss.
Professor Man-Fung Yuen, the Principal Investigator of the trial, stated, "For the first time, we are seeing a meaningful percentage of HBV patients functionally cured with an RNAi therapeutic and interferon."
Safety and Tolerability
The combination therapy was well-tolerated, with no serious adverse events reported. This is a notable improvement over traditional approaches, where only about 10% of patients achieve a functional cure with IFN alone. The enhanced tolerability and higher cure rate suggest a significant advancement in HBV treatment.
Dr. Karen Sims, Chief Medical Officer of Arbutus Biopharma, emphasized the implications of the research: "We are extremely excited to have functionally cured these patients with the imdusiran and interferon treatment regimen. These data support our belief that lowering surface antigen with imdusiran and incorporating an immunomodulator in the treatment regimen provides a functional cure in some patients with cHBV."
Implications for Global Hepatitis B Treatment
Chronic hepatitis B affects over 250 million people worldwide. The success of the IM-PROVE I trial offers a potential pathway to new treatment standards that could significantly benefit patients globally. The trial's findings suggest that a finite curative treatment for HBV may be possible.
Next Steps for Imdusiran
Arbutus Biopharma plans to advance imdusiran into a Phase 2b clinical trial. This progression underscores the company's commitment to developing effective solutions for cHBV treatment and improving patient outcomes.
