Moleculin Biotech Receives FDA Guidance for Phase 3 Trial on Annamycin-Cytarabine Combination

Moleculin Biotech, Inc. (NASDAQ: MBRX) recently announced that it has received crucial feedback and guidance from the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) amendment. This development has allowed for a reduction in the size of the Phase 3 pivotal trial protocol evaluating the Annamycin in combination with Cytarabine for the treatment of Acute Myeloid Leukemia (AML) patients who are refractory to or relapsed after induction therapy. The combination of Annamycin and Cytarabine, referred to as “AnnAraC,” will be evaluated under the Phase 3 “MIRACLE” trial, which stands for Moleculin R/R AML AnnAraC Clinical Evaluation. This global trial will span across sites in the US, Europe, and the Middle East.

As per the 8-K filing made by Moleculin Biotech on February 13, 2025, the company attached a copy of the press release announcing this significant development as Exhibit 99.1. The information disclosed in this report, including the press release, is being provided as a disclosure and not filed under the Securities Exchange Act of 1934, nor incorporated by reference in any filings under the Exchange Act or Securities Act of 1933 unless stated otherwise.

Additionally, the announcement outlined that the Phase 3 trial, named MIRACLE, will involve a global scope with participating sites across different regions. This progression in the clinical trial is a significant step for Moleculin Biotech in advancing potential treatment options for patients with refractory or relapsed AML.

Investors and stakeholders closely following Moleculin Biotech and its advancements in the pharmaceutical industry can refer to the attached press release for further details regarding this important development in their clinical trial program.

Overall, this latest update signifies a positive development for Moleculin Biotech as it progresses its clinical trial program for the treatment of AML patients. The guidance from the FDA is expected to streamline the Phase 3 trial protocol, allowing for efficient evaluation of the Annamycin-Cytarabine combination therapy.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Moleculin Biotech’s 8K filing here.

About Moleculin Biotech

Moleculin Biotech, Inc, a clinical stage pharmaceutical company, focuses on the development of drug candidates for the treatment of cancers and viruses. Its lead drug candidate is Annamycin, which is in Phase 1B/2 clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma metastasized to the lungs.