Late-stage pharmaceutical company Moleculin Biotech Inc (Nasdaq:MBRX) said on Thursday that the US Food and Drug Administration (FDA) has provided feedback and guidance on the company's IND amendment for the Phase 3 pivotal trial protocol assessing Annamycin in combination with Cytarabine (also known as Ara-C and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML).

The feedback and guidance have enabled a reduction in the timeframe of the company's Phase 3 pivotal trial protocol.

The global Phase 3 MIRACLE trial will include sites in the United States, Europe and the Middle East. Subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, the study utilises an adaptive design whereby the first 75 to 90 subjects will be randomised (1:1:1) in Part A of the trial to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin or 230 mg/m2 of Annamycin.

For Part B of the trial, approximately 220 additional subjects will be randomised to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin (randomised 1:1). Selection of the optimum dose will be based on the overall balance of safety, pharmacokinetics and efficacy, consistent with the FDA's new Project Optimus initiative.