$MBRXSep 29, 2026, 8:45 AM ETAI processed
MBRX completes Part A enrollment in pivotal Phase 2/3 MIRACLE; Q1 2027 readout on track
AI Summary
Moleculin (MBRX) has closed enrollment in Part A of its pivotal Phase 2/3 MIRACLE trial in relapsed/refractory AML with 89 subjects enrolled (plus one in screening) and says it remains on track for a comprehensive Part A data readout in Q1 2027. Part A is a randomized, double-blind comparison of two doses of Annamycin + cytarabine versus cytarabine + placebo measured after a single cycle; company expects the full dataset to be ~50/50 between patients previously treated with intensive 7+3 and venetoclax-based regimens and reports continued absence of cardiotoxicity in blinded data.
Positives
- Part A enrollment closed with 89 subjects enrolled (plus one subject in screening)
- Company expects comprehensive Part A data readout in Q1 2027
- Blinded data continue to show no cardiotoxicity signal for Annamycin
Negatives
- Expected ~50/50 split increases proportion of 'unfit' (venetoclax-pretreated) subjects versus earlier interim cohort, which may make responses harder to achieve
- Primary remission rates are assessed after a single cycle, so absolute rates will be lower than multi-cycle historical benchmarks
- Company states it will require significant additional financing with no commitments disclosed