Moleculin Biotech Inc. (NASDAQ:MBRX) moved higher in premarket trading on Tuesday, gaining 6.2% after the company announced that enrollment has reached 78% for the first planned interim unblinding in its pivotal Phase 2B/3 MIRACLE study.
The clinical-stage drug developer said that 78% of the targeted 45 participants have now consented to join the trial, which is assessing Annamycin combined with cytarabine in patients with relapsed or refractory acute myeloid leukemia (AML). The updated figure marks a notable jump from the 60% enrollment level reported in November.
Moleculin expects treatment of the initial 45 subjects to finish during the first quarter of 2026. Participants are now being enrolled across seven countries, and the company noted that blinded clinical activity remains in line with historical response patterns.
The MIRACLE trial is a randomized, double-blind, placebo-controlled, multi-center study aimed at determining whether Annamycin can improve outcomes for AML patients. Although data from the first 45-subject cohort will not be statistically powered, Moleculin hopes the readout will show that at least one of the two dosing regimens outperforms the control arm.
Annamycin—also referred to as naxtarubicin—has received both Fast Track and Orphan Drug designations from the FDA for treating relapsed or refractory AML, and also holds Orphan Drug status for soft tissue sarcoma. The drug is protected by patents through 2040, with possible extensions to 2045.
The company will continue recruiting the remaining participants needed to complete Part A of the study, which targets 90 patients in total. Moleculin anticipates completing Part A in the first half of 2026 while simultaneously evaluating the unblinded data from the initial cohort.