FDA lifts clinical hold on Arbutus’ oral hepatitis B drug AB‑101
Arbutus Biopharma announced that the U.S. Food and Drug Administration removed the clinical hold on the IND for its experimental oral PD‑L1 inhibitor AB‑101, intended to treat chronic hepatitis B. The company said it will assess next steps for further U.S. clinical development. AB‑101 has completed a Phase 1a/1b trial that showed good tolerability, high receptor occupancy in seven patients and hepatitis B surface antigen decline in two patients at the 30 mg dose.
Why it matters
Arbutus said the lift enables additional U.S. clinical trials for AB‑101, which could move the candidate closer to market and improve the company’s pipeline outlook.
Key facts
- 1The FDA notified Arbutus that the clinical hold on the IND for AB‑101 has been removed. stocktitan.net
- 2AB‑101 is an oral PD‑L1 inhibitor being developed for chronic hepatitis B infection. stocktitan.net
- 3AB‑101 completed a Phase 1a/1b trial evaluating safety, tolerability, pharmacokinetics and pharmacodynamics. stocktitan.net
- 4The trial showed high receptor occupancy in seven chronic HBV patients and hepatitis B surface antigen decline in two patients at the 30 mg dose. stocktitan.net
- 5Arbutus is evaluating next steps for continued development of AB‑101 in the United States. stocktitan.net
- 6The announcement was made on October 22 2026. stocktitan.net
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.