The U.S. Food and Drug Administration (FDA) on Thursday lifted the clinical hold on Arbutus Biopharma Corporation’s (NASDAQ:ABUS) Investigational New Drug (IND) application for AB-101.
The company can engage in additional clinical development for AB-101 in the U.S.
The FDA update comes after more than three years, when the FDA placed a clinical hold in April 2023. Arbutus is evaluating next steps for the continued development of AB-101.
AB-101 Mechanism Of Action And Phase 1 Trial Results
AB-101 is a proprietary oral PD-L1 inhibitor that has the potential to activate patients’ hepatitis B virus (HBV)-specific immune response by inhibiting PD-L1.
It has completed a Phase 1a/1b clinical trial (AB-101-001) evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single- and multiple-ascending oral doses in healthy subjects and patients with chronic HBV (cHBV) infection.
The data from healthy subjects in Parts 1 and 2 and cHBV patients in Part 3 of this clinical trial have shown that AB-101 was generally well-tolerated, with evidence of high receptor occupancy in seven cHBV patients and hepatitis B surface antigen decline in two cHBV patients at the 30mg dose.
In August, Arbutus Biopharma announced plans to repurchase up to $230 million of its common stock through a modified Dutch auction tender offer.
The clinical-stage biotech plans to offer shareholders between $5 and $5.75 per share in cash. Arbutus expects to fund the buyback with cash on hand.
CEO Lindsay Androski linked the planned buyback to the company’s March 2026 settlement with Moderna Inc. (NASDAQ:MRNA) and the initial payment received in July.
Arbutus received approximately $178 million as its share of the noncontingent settlement payment, including reimbursement of litigation costs.
ABUS Price Action: Arbutus Biopharma shares were up 3.95% at $4.34 at the time of publication on Thursday, according to Benzinga Pro data.
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