Moleculin Biotech, Inc. provided an update on the enrollment progress of its pivotal Phase 2B/3 'MIRACLE' study for the treatment of adult patients with acute myeloid leukemia (AML).
Enrollment has reached 78% of the target number of subjects, showing significant progress from the previous report.
Treatment for the first 45 subjects is expected to be completed in the first quarter of 2026.
Enrollment Progress
Enrollment increased to 78% of the target, demonstrating strong interest and cooperation from investigators across seven countries.
Clinical Activity Tracking
Blinded response activity is within the expected range, indicating positive results from the trial so far.
Outlook on Annamycin
Expectations that Annamycin combined with cytarabine may outperform the control arm, potentially supporting approval in the future.
- The enrollment progress of the MIRACLE trial showcases growing interest and support from investigators in Europe and the US.
- The expected completion of treatment for the first 45 subjects in early 2026 marks a significant milestone in the trial's advancement.
Moleculin Biotech's progress in enrollment and treatment completion for the AML trial underscores the potential of Annamycin in offering a valuable treatment option for AML patients. The company's commitment to advancing the MIRACLE trial is a positive step in addressing the unmet medical needs in AML treatment.