Moleculin Biotech Inc. (NASDAQ:MBRX) said it remains on track to unblind the first set of data from its pivotal Phase 2B/3 MIRACLE trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML), before June 30, 2026.
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The MIRACLE study is comparing two dosing arms of Annamycin plus cytarabine against a control arm using cytarabine with placebo in patients whose disease returned or failed to respond after initial treatment.
Early Blinded Data Shows Higher Remission Rates
The company said preliminary blinded efficacy data from 45 subjects continue to align with previously disclosed results. Moleculin reported a composite complete remission rate exceeding 40% and a complete remission rate of about 30%.
According to the company, those figures compare with historical complete remission rates of roughly 17% to 18% seen in prior studies using cytarabine alone in similar patient populations.
Moleculin added that the median age of enrolled patients is in the mid-60s. More than 30% of participants previously received venetoclax-based frontline therapy before relapsing or becoming refractory, a subgroup considered difficult to treat.
As of May 1, the company had recruited 56 patients and said it remains on pace to enroll the 90th patient in Part A during the third quarter of 2026.
CEO Highlights Potential Improvement Over Current Standard Of Care
Walter Klemp, chairman and CEO of Moleculin, said the company believes the trial could demonstrate that Annamycin adds meaningful benefit when combined with cytarabine.
Klemp noted that cytarabine monotherapy has historically produced relatively modest remission rates in relapsed or refractory AML patients. He said the emerging MIRACLE data may indicate progress beyond current standard-of-care outcomes.
MIRACLE Trial Continues Enrollment
The MIRACLE trial is a global, randomized, double-blind, placebo-controlled adaptive study. Part A will evaluate Annamycin at doses of 190 mg/m² and 230 mg/m² alongside cytarabine.
The study design allows for preliminary efficacy data unblinding after the first 45 patients and again after enrollment of all 90 patients in Part A.
Moleculin expects the second group of 45 patients to be fully recruited in the second half of 2026 while enrollment continues during the ongoing unblinding process.
MBRX Price Action: Moleculin Biotech shares were down 5.13% at $2.22 at the time of publication on Wednesday, according to Benzinga Pro.
Over the past month, MBRX has declined about 18.32% versus a 9.2% rise in the S&P 500 and is down roughly 32.88% year-to-date compared to the index’s 7.9% gain.
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