Moleculin CEO discusses early MIRACLE trial data in investor segment

Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that Chairman and Chief Executive Officer Walter Klemp participated in a Virtual Investor "What This Means" segment to discuss preliminary unblinded efficacy results from the MIRACLE trial.

The segment covers early efficacy data from the first 45 patients enrolled in Part A of the pivotal Phase 2/3 MIRACLE trial, which is evaluating Annamycin in combination with cytarabine, known as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Klemp summarized key data points and discussed early efficacy trends observed across both Annamycin treatment arms.

The company noted in its press release that the interim results are based on a small sample size of 45 patients, have not achieved statistical significance, and may not be predictive of results from the completed trial.

Klemp also addressed the commercial opportunity for Annamycin, citing findings from the company's market research assessing the potential addressable market if the drug receives regulatory approval.

The MIRACLE trial is a pivotal, adaptive design, multi-center, randomized, double-blind, placebo-controlled Phase 2/3 study. Moleculin states the trial follows a successful Phase 1B/2 study conducted with input from the FDA.

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