Moleculin secures EMA approval to expand acute myeloid leukaemia trial across EU
Ella Day | May 16, 2025 | News story | Research and Development | Clinical Trial Application (CTA), European Union (EU), FDA, Food and Drug Administration, Moleculin Biotech, Oncology, Orphan Drug Designation (ODD), acute myeloid leukaemia
Moleculin Biotech has received approval from the European Medicines Agency (EMA) to expand its phase 3 ‘MIRACLE’ trial into nine additional EU countries — a key milestone in the development of its acute myeloid leukaemia (AML) treatment.
The approval allows the company to proceed with its Clinical Trial Application (CTA) for the MIRACLE study, which investigates Annamycin in combination with cytarabine, referred to as AnnAraC, for patients with relapsed or refractory (R/R) AML.
Enrolment and dosing are already underway. Belgium, Czechia, France, Germany, Italy, Lithuania, Poland, Romania and Spain have joined the trial, which now includes sites across Europe, the US and the Middle East. An initial data readout remains on track for the second half of 2025.
“This approval from the EMA positions us to remain on track with our expected enrolment and data milestones,” said Walter Klemp, chairman and CEO of Moleculin.
Annamycin currently holds Fast Track and Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of R/R AML, as well as ODD for soft tissue sarcoma. It also has ODD from the EMA for AML.
Klemp added: “We are grateful for the international collaboration and believe it underscores the significant unmet need in R/R AML and the potential of Annamycin to provide a much-needed second-line treatment option.”
Ella Day
16/5/25
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