Moleculin Completes Dosing Patients in Part A of Pivotal MIRACLE Trial; Comprehensive Data Readout on Track for Q1 2027
Globe Newswire•30/10/2026•08:40 ET
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Key Highlights
- ➤Moleculin completed dosing in randomized, double-blind n=90 Part A population
- ➤Q1 2027 comprehensive Part A data readout remains on track
- ➤Part A expected to inform Annamycin dose selection for MIRACLE Part B
- ➤Final Part A population expected approximately 50/50 across 7+3 and venetoclax failures
- ➤Blinded interim data reportedly show continued absence of cardiotoxicity
Expert Statements
Walter Klemp, Chairman and Chief Executive Officer of Moleculin
“Reaching the completion of dosing in Part A represents another important step toward our planned Q1 2027 comprehensive n=90 data readout”
Walter Klemp, Chairman and Chief Executive Officer of Moleculin
“Combined with the continued absence of cardiotoxicity in blinded interim data, we believe our Q1 2027 readout positions us to select our Part B dose and to define Annamycin's potential role across today's R/R AML landscape.”
Milestone underscores execution of pivotal Phase 2/3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML)
Fully treated, randomized, double-blind n=90 Part A population sets up Annamycin dose selection for Part B, with balanced representation of AML patients who failed 7+3 chemotherapy and venetoclax-based regimens
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