Moleculin enrolls first EU patients in pivotal Phase 3 MIRACLE trial for R/R AML

Moleculin Biotech, Inc.

First two subjects enrolled, one treated in Spain; active sites in US, Spain, Ukraine, Georgia, Romania.
Goal to recruit 45 subjects for Part A unblinding by end of 2025; initial data readout in 2H 2025.
Phase 2B/3 adaptive design with Annamycin+cytarabine vs placebo; FDA Fast Track and Orphan Drug designations.
Part A randomizes 1:1:1 to HiDAC+placebo, 190 or 230 mg/m² Annamycin; Part B adds ~220 subjects.
EMA approval conditional on nonclinical GLP results before Part B.

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