Moleculin’s MIRACLE Trial Posts 40% CRc Rate, Q1 2026 Unblinding
Moleculin Biotech’s MIRACLE Phase 2B/3 trial of Annamycin plus cytarabine achieved a blinded 40% composite complete remission rate (30% CR, 10% CRh) in 30 patients, representing a 67% improvement over historical cytarabine outcomes. Enrollment has reached 35 subjects with unblinding of data for 45 patients expected in Q1 2026.
1. Trial Interim Efficacy
The MIRACLE Phase 2B/3 study reported a blinded composite complete remission rate of 40% in its first 30 evaluable patients, comprising a 30% complete remission rate and a 10% CRh rate. This outcome represents a 67% improvement over historical cytarabine response rates of approximately 17–18%.
2. Enrollment Progress
To date, 35 subjects have been treated and another 11 are in screening or identified, advancing toward the 45-patient threshold required for the first unblinding of efficacy data. The company expects to treat the 45th subject and conduct the unblinding in Q1 2026.
3. Safety and Patient Profile
No cardiotoxicity has been observed across treated participants, and roughly 35% of subjects represent venetoclax regimen failures—a particularly challenging relapsed/refractory AML cohort. Genetic markers predictive of poor response were prevalent, underscoring the trial’s rigorous patient population.
4. Next Steps and Outlook
Upon unblinding for 45 patients, the company will reveal preliminary efficacy by dosing arm and control arm, potentially driving partnerships and value inflection. Frequent updates are planned to maintain visibility on timing and future milestones.