Moleculin Accelerates Recruitment in Phase 3 Acute Myeloid Leukemia “MIRACLE” Clinical Trial

Core Insights - Moleculin Biotech, Inc. is advancing its pivotal Phase 2B/3 clinical trial, named MIRACLE, for Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia (AML) [1][10] - The company aims to recruit a total of 45 patients by Q4 2025 for initial data unblinding, with 13 subjects already recruited as of September 2025 [1][2][4] Recruitment and Trial Progress - The company has expanded its recruitment sites to include countries such as Georgia, Italy, Lithuania, Poland, Romania, Spain, and the US, with a goal of treating, enrolling, or screening 20 subjects by the end of September [1][4] - The recruitment strategy is on track, with expectations to increase active sites to over 30 by year-end, facilitating the recruitment of an additional 30 to 45 subjects for the trial [2][4] Trial Design and Data Insights - The MIRACLE trial employs an adaptive design, allowing for preliminary unblinding of efficacy data at 45 subjects, with a focus on complete remission (CR) rates [3][6] - The first unblinding is expected to provide insights into the efficacy and safety of Annamycin in combination with high-dose cytarabine, with a second unblinding anticipated in the first half of 2026 [3][4] Regulatory and Development Status - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for treating relapsed or refractory AML, along with patent protection extending to 2040, potentially to 2045 [8][9] - The company is required to present results from nonclinical GLP studies to the EMA before initiating Part B of the trial, which will involve approximately 220 additional subjects [5][6]