Moleculin Biotech (NASDAQ:MBRX) Receives First Country Regulatory Approval in Europe for Phase 3 Clinical Trial Protocol for Annamycin Combination

On February 11, 2025, Moleculin Biotech, Inc. (the “Company”) disclosed in a press release that it has obtained its initial country regulatory approval in Europe to commence recruitment for the Phase 3 pivotal trial protocol evaluating Annamycin coupled with Cytarabine for the treatment of Acute Myeloid Leukemia (AML) patients who have not responded to or have relapsed after induction therapy (R/R AML) (MB-108). The Company finalized the necessary regulatory approvals from the Ministry of Health in Ukraine last week. The Phase 3 trial, dubbed “MIRACLE” (Moleculin R/R AML AnnAraC Clinical Evaluation), will be conducted globally, with participation from locations in the US, Europe, and the Middle East.

In a move towards progressing its clinical trial pipeline, the company’s announcement under Item 7.01 of the Form 8-K filing highlights the strategic development related to the global Phase 3 trial. This significant milestone underscores Moleculin Biotech’s commitment to advancing innovative therapies in the treatment of AML.

A copy of the press release is attached to the filing as Exhibit 99.1, providing further details on this regulatory approval and the initiation of the trial protocol. It is emphasized that the information in this Current Report on Form 8-K, including the press release, is offered for informational purposes and is not to be construed as a formal filing under the Securities Exchange Act of 1934 or incorporated by reference unless explicitly stated.

Moreover, the company also indicated under Item 9.01 of the filing that Exhibit 99.1 encompasses the press release issued on February 11, 2025. Additionally, a Cover Page Interactive Data File formatted as an Inline XBRL document is provided as Exhibit 104 for reference.

In conclusion, Moleculin Biotech’s recent regulatory approval in Europe marks a pivotal moment in its progress towards conducting the Phase 3 clinical trial for the treatment of AML patients. The “MIRACLE” trial holds promise for addressing unmet medical needs in the AML treatment landscape and underscores the company’s dedication to advancing innovative solutions in the field of biotechnology.

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.

Moleculin Biotech Company Profile

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.