Arbutus Biopharma said the U.S. Food and Drug Administration granted fast track designation to imdusiran for chronic hepatitis B, a regulatory step that could speed development and review of the drug.
The company highlighted clinical results that, so far, include functional cure in 10 chronic hepatitis B patients. That total includes eight patients from phase 2a trials who achieved functional cure after treatment with imdusiran and nucleos(t)ide analogue therapy, paired with either pegylated interferon alfa-2a or low-dose nivolumab plus an immunotherapeutic. Of those eight, six have sustained functional cure for more than two years.
Arbutus also said 41 additional patients across its phase 2a trials were able to stay off nucleos(t)ide analogue therapy for at least 48 weeks after treatment with imdusiran. Two more patients who had discontinued nucleos(t)ide analogue therapy later achieved functional cure during long-term follow-up.
The company said imdusiran has shown meaningful reductions in both HBsAg and HBV DNA in its clinical studies and has been generally safe and well tolerated.
Chronic hepatitis B remains a large market opportunity. Arbutus cited estimates of more than 250 million people worldwide living with the disease and about 2 million in the U.S. It also said roughly 1.1 million people die each year from complications related to chronic hepatitis B. As a result of these announcements, the company's shares have moved -1.77% on the market, and are now trading at a price of $4.45. For the full picture, make sure to review Arbutus Biopharma Corp's 8-K report.
