Moleculin Reaches 45 Enrollments in Phase 2B/3 AML Trial, Data Unblinding Set for Mid-2026
MBRX•Moleculin Biotech has enrolled the 45th patient in its pivotal Phase 2B/3 MIRACLE trial evaluating Annamycin plus cytarabine for relapsed or refractory acute myeloid leukemia. This milestone initiates final preparations for the interim unblinding of 45-subject data scheduled for mid-2026.
1. Enrollment Milestone
Moleculin Biotech has enrolled 45 subjects in its pivotal Phase 2B/3 MIRACLE trial evaluating Annamycin in combination with cytarabine for relapsed/refractory acute myeloid leukemia. This achievement meets the threshold for the planned interim analysis and reflects steady recruitment in the study.
2. Interim Data Unblinding
The 45th enrollment triggers final preparations for unblinding interim safety and efficacy data, set for mid-2026. Successful interim results could serve as a defining inflection point for the program and influence subsequent trial expansion and regulatory interactions.
3. Trial Design and Pipeline Context
The adaptive design of the MIRACLE trial builds on earlier Phase 1B/2 findings to assess the combination therapy’s potential to overcome multidrug resistance and reduce cardiotoxicity. Moleculin’s broader pipeline includes immune/transcription modulators and antiviral antimetabolites, underscoring its focus on hard-to-treat tumors and viruses.
