Moleculin Gets FDA Guidance To Accelerate MIRACLE Trial For R/R AML

(RTTNews) - Moleculin Biotech, Inc., (MBRX) an US-based pharmaceutical company Thursday announced the FDA feedback on its IND amendment, allowing a reduced Phase 3 trial size for Annamycin with Cytarabine also known as AnnAraC in treating R/R AML patients. The global "MIRACLE" trial will span the US, Europe, and the Middle East.

The MIRACLE study will test a new treatment for AML by combining a standard drug (HiDAC) with either a placebo or two different doses of Annamycin, as recommended by the FDA. The trial will start with 75-90 patients, and early results on effectiveness and safety will be reviewed after 45 patients. The first review is expected in late 2025 and the second in early 2026, with faster progress due to strong interest from doctors in joining the study.

In Part B of the trial, about 220 more patients will be randomly assigned to receive either HiDAC with a placebo or HiDAC with the best-performing Annamycin dose. The optimal dose will be chosen based on safety, effectiveness, and how the drug is processed in the body, following FDA's Project Optimus guidelines.

Annamycin holds Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML and soft tissue sarcoma. It also has Orphan Drug Designation for AML from the European Medicines Agency or EMA.

MBRX is currently trading at $1.7 or 304.7620% higher on the Nasdaq Capital Market.