WARMINSTER, PA — Arbutus Biopharma Corporation (Nasdaq: ABUS) announced that the U.S. Food and Drug Administration has granted Fast Track designation to its drug candidate imdusiran for the treatment of chronic hepatitis B.
The designation is intended to expedite the development and review of therapies for serious conditions with unmet medical needs, including more frequent interactions with regulators and potential eligibility for accelerated approval or priority review.
Imdusiran is an RNA interference therapeutic designed to reduce hepatitis B viral proteins and antigens, including hepatitis B surface antigen, which plays a role in suppressing the immune response to the virus.
In Phase 2a clinical trials, eight patients achieved a functional cure following treatment with imdusiran in combination with other therapies, with six maintaining that response for more than two years. Two additional patients later achieved functional cure during long-term follow-up, according to the company.
The company said 41 additional patients in trials were able to remain off standard antiviral therapy for at least 48 weeks following treatment with imdusiran.
“Imdusiran … has achieved functional cure for 10 chronic hepatitis B patients to date,” said CEO Lindsay Androski, adding that the designation supports continued development of the therapy.
Chronic hepatitis B affects an estimated 250 million people worldwide and about 2 million people in the United States, according to global health estimates, and can lead to cirrhosis, liver cancer, and death.
Arbutus is developing imdusiran and an oral PD-L1 inhibitor as part of its pipeline targeting chronic hepatitis B infection.
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