Moleculin Biotech receives approval in Italy for Phase 1/2 trial of Annamycin

Moleculin Biotech announced it has received approval from the Agenzia Italiana del Farmaco, or AIFA, the Italian Medicines Agency competent authority, and the Istituto Superiore di Sanita, or ISS, the Italian National Institute of Health, for its Phase 1/2 trial evaluating Annamycin in combination with Cytarabine, or Ara-C, in the treatment of subjects with AML who are refractory to or relapsed after induction therapy, or MB-106. This adds to the approval the Company already has in Poland where three sites are currently open and recruiting subjects. Additionally, the Company has ongoing efforts to open additional clinical sites in Poland and Italy and gain approval to proceed in other European countries for the MB-106 clinical trial to potentially improve recruitment rates. Annamycin is the Company’s next-generation anthracycline that has been designed to be non-cardiotoxic and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory AML and STS lung metastases and the Company believes it may have the potential to treat additional indications. The Phase 1/2 MB-106 trial is an open label trial that builds on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials conducted in the U.S. and Europe. Additionally, the preclinical animal data from sponsored research demonstrated Annamycin in combination with Cytarabine had a 68% improvement in the median overall survival compared to Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone.Subject enrollment and screening for the MB-106 trial is underway and the Company expects to initiate subject treatment in the near term and the first subject to be treated in Italy in the Q1 of 2023.