Moleculin Biotech has dosed the first subjects in the Phase II portion of a Phase Ib/II trial evaluating the company’s anthracycline candidate in combination with Cytarabine (Ara-C) for the treatment of acute myeloid leukaemia.

The study (NCT05319587) is a multicentre, open-label, dose-escalation trial evaluating safety and dosage data of the company’s candidate Annamycin. Moleculin has already successfully conducted two single-agent trials with Annamycin in the US and Europe.

In July 2023, the Houston, US-based pharma company announced positive results from the European study. The data, which was published in the British Journal of Cancer Research, demonstrated a safe and efficacious dose of 230 mg/m². The same dose is being used in the Phase II portion.

Patients will receive a two-hour intravenous (IV) infusion of liposomal Annamycin daily for three consecutive days followed by 18 days off the drug, for a treatment cycle time of 21 days. Cytarabine, a standard chemotherapy drug, will also be administered at a dose of 2.0 g/m² per day for hours by IV infusion for 5 consecutive days.

In December 2020, the US Food and Drug Administration (FDA) granted orphan drug designation to Annamycin for soft tissue sarcoma lung metastases. A Fast Track designation followed in March 2021. Moleculin recently completed enrolment in a trial of the candidate for STS lung metastases treatment.

Moleculin chairman and CEO Walter Klemp said: “Based on the positive preliminary results demonstrated in the Phase Ib portion of this trial, we continue to believe that Annamycin has the potential to be a meaningful treatment option for the treatment of AML.”