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A novel siRNA drug, HRS-5635, is showing real promise against chronic hepatitis B. In a phase II trial, 19% of patients on the highest dose achieved a functional cure 24 weeks after completing treatment — matching results seen with the recently FDA-approved bepirovirsen. The drug was well-tolerated, with no serious treatment-related adverse events or deaths.
The chronic hepatitis B treatment landscape is heating up. A phase II trial of HRS-5635 — a novel small interfering RNA (siRNA) therapy — showed that patients on the highest dose (400 mg) achieved meaningful reductions in hepatitis B surface antigen (HBsAg), with 19% reaching a functional cure 24 weeks after finishing treatment. This mirrors the ~20% functional cure rate seen with bepirovirsen (Hibsago), the antisense oligonucleotide drug the FDA approved last month for the same condition.
All four doses of HRS-5635 hit the primary endpoint of HBsAg reduction from baseline at week 12, and the drug was generally safe and well-tolerated across the board — with no serious treatment-related adverse events and no deaths reported. A longer extension study and a phase III trial are already underway.
By the Numbers:
Why it matters: For decades, a functional cure for chronic hepatitis B — a disease that can lead to cirrhosis and liver cancer — has been an elusive goal. With HRS-5635 now joining bepirovirsen in demonstrating meaningful functional cure rates, clinicians may soon have multiple nucleic acid-based options to offer patients, potentially transforming long-term management of this serious infection.
