Moleculin Expands Phase 3 MIRACLE Clinical Trial into the Country of Georgia, Enrollment Update and Future Plans

Core Points - The Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia has approved the Clinical Trial Application (CTA) for the pivotal Phase 2B/3 MIRACLE trial of Annamycin in combination with cytarabine for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) [2][3] - The European Medicines Agency (EMA) has also granted approval for the trial, enhancing its profile and recruitment efforts [3][5] - Enrollment in Part A of the MIRACLE trial has reached seven subjects treated, with one additional subject in screening, and the company plans to expand to over 30 clinical sites by the end of the year [3][4] Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viral infections, with Annamycin as its lead program [11][12] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for treating relapsed or refractory AML, as well as similar designations from the EMA [8][11] - The MIRACLE trial is designed to combine data from the Phase 2B and Phase 3 portions to measure the primary efficacy endpoint, utilizing an adaptive design [3][12] Trial Details - The MIRACLE trial will randomize the first 75 to 90 subjects to receive high-dose cytarabine combined with either placebo or two different doses of Annamycin [3][6] - The first unblinding of preliminary efficacy data is expected in the second half of 2025, with a second unblinding anticipated in the first half of 2026 [4][6] - Approximately 220 additional subjects will be randomized in Part B of the trial to receive either high-dose cytarabine plus placebo or the optimum dose of Annamycin [6] Recruitment and Collaboration - The company expects to add 16 additional clinical sites in Europe and the US by the end of August, building to over 30 sites for Part A of the trial [3][4] - The recruitment success is attributed to the capabilities of clinical sites, particularly the ARENSIA Exploratory Medicine's research clinic in Kyiv, Ukraine [3][9]