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Moleculin Announces Imminent MIRACLE Trial Unblinding as Blinded Data Continue to Significantly Outperform Historical Benchmarks
Preliminary blinded CR rate for the first 45 subjects in the trial approximates 30% and represents ~67% improvement vs. standard of careFirst 45-subject data unblinding expected before June 30, 2026Program targets high-unmet-need AML population, including R/R Venetoclax subjects Recruitment of Part A continues to the target 90 subjects in Q3 2026 with 56 or 62% subjects recruited and randomizedContinued absence of cardiotoxicity and high efficacy expected to position Annamycin as a “significant
About this update from Moleculin Biotech, Inc.
Preliminary blinded CR rate for the first 45 subjects in the trial approximates 30% and represents ~67% improvement vs. standard of careFirst 45-subject data unblinding expected before June 30, 2026Program targets high-unmet-need AML population, including R/R Venetoclax subjects Recruitment of Part A continues to the target 90 subjects in Q3 2026 with 56 or 62% subjects recruited and randomizedContinued absence of cardiotoxicity and high efficacy expected to position Annamycin as a “significant advancement” in AML treatment HOUSTON, May 13, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that it is approaching the first unblinding of data from its pivotal Phase 2B/3 “MIRACLE” trial evaluating Annamycin in combination with cytarabine for the treatment of subjects that have been relapsed or refractory to their primary line of treatment for acute myeloid leukemia (R/R AML). The trial incorporates two arms of Annamycin at different doses plus cytarabine compared to the control arm of cytarabine plus a placebo. The Company continues to expect this unblinding to occur prior to June 30, 2026, as previously communicated. The Company also reported that preliminary blinded efficacy data for the 45 subjects continue to approximate previously disclosed results, including a composite complete remission rate (CRc) exceeding 40% and a complete remission (CR) rate of approximately 30%. These results compare favorably to historical CR rates from two major trials of approximately 17–18% observed with cytarabine alone in similar patient populations. Cytarabine is a currently approved standard of care for second line treatment of AML. Based on preliminary data, the median age for subjects enrolled is in the mid-60’s, with over 30% entering the trial after becoming relapsed from or refractory (R/R) to a prior venetoclax regimen as first line therapy, which is considered a particularly challenging patient group. As of May 1st, a total of 56 subjects have been recruited in the MIRACLE trial to date keeping the Company on track to recruit the 90th subject in Part A in Q3 2026. “The data coming from MIRACLE is encouraging” said Walter Klemp, Chairman and CEO of Moleculin. “For decades, cytarabine monotherapy regimens, although one of the current standards of care, have set a relatively low bar in relapsed or refract...
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