Moleculin Biotech, Inc. announced enrollment of the first two subjects, treating one, in the EU for the Phase 2B/3 MIRACLE trial for AML treatment.
The MIRACLE trial is a global Phase 2B/3 study evaluating Annamycin in combination with cytarabine for refractory AML patients.
The company aims to recruit 45 subjects by 4Q25 for initial data unblinding.
MIRACLE Trial Progress
Enrollment of first EU patients in Phase 3 trial shows advancement in AML treatment development.
Global Approval Study
The MIRACLE trial is a double-blind, placebo-controlled study in multiple regions, including the US and Europe.
Annamycin's Designation
Annamycin holds Fast Track and Orphan Drug Designations from FDA and EMA for AML treatment.
- The fast enrollment in the EU signifies the urgent need for effective second-line AML treatments.
- Expanded sites globally indicate positive response and potential for broader patient reach.
- Scaling up patient dosing aligns with accelerated timeline, showcasing efficient trial management.
Moleculin's progress in the MIRACLE trial marks significant strides in AML therapy, with promising results expected by 2026. The company's focus on hard-to-treat cancers is pivotal for advancing innovative treatment options in oncology.