Moleculin CEO discusses Annamycin MIRACLE trial progress

Moleculin Biotech, Inc. (Nasdaq: MBRX) released a new segment of its CEO Corner video series in which Chairman and CEO Walter Klemp discussed the progress of the company's Phase 2/3 MIRACLE trial evaluating Annamycin in combination with high-dose cytarabine for patients with second-line relapsed or refractory acute myeloid leukemia (AML).

According to the press release, enrollment in Part A of the trial has been completed. Klemp noted encouraging interim efficacy results and outlined the next steps toward the pivotal Part B expansion. A full 90-patient Part A data readout is anticipated in the first quarter of 2027.

The MIRACLE trial is a pivotal, adaptive design, multi-center, randomized, double-blind, placebo-controlled study. Moleculin states that Annamycin, also known as naxtarubicin, is designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity associated with currently prescribed anthracyclines, though the company notes it relies on expert reports regarding the absence of cardiotoxicity.

Moleculin also noted that completing the clinical program will require significant additional financing, for which the company currently has no commitments.

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