US-based pharmaceutical company Moleculin Biotech has begun dosing subjects in its Phase III MIRACLE trial of Annamycin with cytarabine for treating acute myeloid leukaemia (AML).
The trial has enrolled individuals who are refractory to or have relapsed (r/r) after induction therapy at sites across Europe, the Middle East and the US.
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Moleculin Biotech chairman and CEO Walter Klemp said: “The start of patient dosing represents a huge milestone for Moleculin and, importantly, the AML community.
“Our team remains focused on bringing clinical sites online in the US, Europe and the Middle East and enrolling patients to build on this momentum.”
The MIRACLE study is a combined Phase IIb/III clinical trial that will merge data from both phases to assess its primary endpoint.
The trial employs an ‘adaptive’ design, with the first 75 to 90 participants being randomised in Part A to receive high-dose cytarabine (HiDAC) in combination with either 190mg/m² or 230mg/m² of Annamycin or a placebo.
The US Food and Drug Administration (FDA) recommended these doses of Annamycin following a Phase Ib/II trial of the drug.
In Part B of the MIRACLE trial, around 220 additional participants will be given either HiDAC with a placebo or HiDAC with the optimum dose of Annamycin.
The optimum dose selection is based on the balance of pharmacokinetics, efficacy and safety, aligning with the FDA’s Project Optimus initiative.
The FDA has given orphan drug and fast-track status to Annamycin for r/r AML. The therapy also holds orphan drug status for soft tissue sarcoma treatment.
The European Medicines Agency has similarly designated Annamycin as an orphan drug for r/r AML.
In September 2023, Moleculin Biotech finished enrolling subjects in the second phase of its Phase Ib/II MB107 trial of Annamycin for treating soft tissue sarcoma lung metastases.
