Moleculin Biotech Inc. Expands Clinical Trials in Georgia

In a significant development for Moleculin Biotech Inc., the company has received approval from Georgia’s Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) to conduct its pivotal Phase 2B/3 MIRACLE clinical trial. This trial focuses on the treatment of relapsed/refractory acute myeloid leukemia (R/R AML) using a combination of Annamycin and cytarabine, known as AnnAraC.

The MIRACLE study, which has already shown early progress with seven subjects treated and one in screening, is set to expand significantly. Moleculin plans to increase its clinical sites from the current number to over 30 by the end of August, with 16 additional sites expected to begin recruitment by then. This expansion is part of a broader strategy to enhance the trial’s reach and gather comprehensive data.

The trial’s adaptive design includes Part A, which will randomize 75-90 subjects across three arms, followed by Part B with approximately 220 additional subjects. Initial data from the first 45 subjects is anticipated in the second half of 2025. Annamycin, the drug under investigation, currently holds Fast Track Status and Orphan Drug Designation from both the FDA and EMA, underscoring its potential in addressing unmet medical needs in cancer treatment.

Moleculin Biotech, headquartered in Houston, Texas, operates within the Health Care sector, focusing on biotechnology. The company, which went public on June 2nd, 2016, has a market capitalization of $8.19 million as of July 7, 2025. Despite a challenging financial landscape, with a close price of $0.521 and a 52-week low of $0.25, the company remains committed to advancing its pipeline of anti-cancer drug candidates.

This expansion into Georgia not only marks a significant milestone for Moleculin but also highlights the growing international interest in its innovative treatment approaches. As the company continues to build its clinical infrastructure, stakeholders eagerly await the forthcoming data, which could potentially transform the treatment landscape for AML patients worldwide.