Mirum Pharmaceuticals reported that the primary endpoint was achieved in the Phase 2b portion of the AZURE‑1 study of Brelovitug, a monoclonal antibody designed to neutralize hepatitis B and hepatitis D virions. The announcement, made on April 27, 2026, confirms that the drug met its predefined virologic response criteria in the late‑stage portion of the trial.
The study data show that 100 % of patients in the 300 mg once‑weekly (QW) arm achieved virologic response, while 75 % of patients in the 900 mg once‑every‑four‑weeks (Q4W) arm achieved the same endpoint. In addition, the composite primary endpoint of virologic response and alanine aminotransferase (ALT) normalization was achieved in 45 % of patients in the 300 mg QW arm and 35 % in the 900 mg Q4W arm. These results represent a significant therapeutic advance in chronic hepatitis Δ, a disease with no approved U.S. treatments and a high mortality rate.
Mirum’s acquisition of Bluejay Therapeutics on January 26, 2026 for up to $820 million brought worldwide rights to Brelovitug into its portfolio. The acquisition has strengthened Mirum’s rare‑disease pipeline and positioned the company to pursue a global Phase 3 program. The company plans to present full Phase 2b results at the European Association for the Study of the Liver (EASL) Congress in late May 2026, with topline Phase 3 data expected in the second half of 2026 and a potential Biologics License Application (BLA) submission and U.S. commercial launch targeted for 2027.
"These results reinforce the potential for brelovitug as a well‑tolerated, convenient, single‑agent therapy to address a critical unmet need in HDV," said Nancy Shulman, M.D., Executive Vice President of Clinical Development at Mirum. "We observed robust antiviral activity, including 100 % virologic response in the 300 mg arm at Week 24. We look forward to the Phase 3 results later this year."
Chris Peetz, CEO of Mirum, added, "With the acquisition now complete, our focus shifts to execution – adding the talented Bluejay team to Mirum as we complete the AZURE Phase 3 program for HDV and prepare for potential registrations and launches." The announcement was well received by the market, with analysts noting the significance of the data and the strategic importance of the Bluejay acquisition for Mirum’s rare‑disease portfolio.
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