Moleculin expects first pivotal trial data readout in Q1 2026

Moleculin Biotech Inc. (NASDAQ: MBRX) announced expected milestones for its drug development programs, with the first data unblinding from its pivotal MIRACLE trial anticipated in the first quarter of 2026.

The Houston-based pharmaceutical company is conducting the Phase 3 MIRACLE trial evaluating Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia. The global trial now spans nine countries including the United States, Spain, Italy, Poland, Czechia, Romania, Ukraine, Lithuania and Georgia, with over 46 sites selected and about 20 sites contracted.

The company expects to treat the 45th subject in Part A of the MIRACLE trial in Q1 2026, with data unblinding to follow shortly thereafter. A second unblinding is expected in Q3 2026 after treating 90 subjects. Part B of the trial is scheduled to begin in the second half of 2026.

Atlantic Health has indicated intent to fund and conduct an investigator-initiated trial with Annamycin for third-line pancreatic cancer treatment, expected to start in 2026. The trial builds on preclinical data showing activity in pancreatic cancer models.

For its WP1066 program, Northwestern University is conducting an externally funded Phase 2 trial combining the drug with radiation for glioblastoma brain cancer treatment. Emory University has indicated interest in conducting a follow-on trial based on positive results from a recently published Phase 1 study.

"We are extremely grateful to these two great institutions for their willingness to fund further investigator-initiated clinical activity with WP1066," said Walter Klemp, Chairman and CEO of Moleculin.

The company projects primary efficacy data for the MIRACLE trial in 2028, with rolling new drug application submission beginning the same year.

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