Launch of MIRACLE Phase 3 Trial
Moleculin Biotech has launched the MIRACLE Phase 3 pivotal trial for Annamycin in combination with Cytarabine for the second line treatment of relapsed and refractory AML patients. Regulatory and ethics approval has been obtained in the first European country, and patient screening has begun.
Positive Phase 2 Data for Annamycin
Phase 2 data shows Annamycin achieving a 50% complete remission rate in second-line AML patients, with a median progression-free survival of nine months and overall survival at 11 months. The drug has shown better performance than any existing therapies with a comparable CR rate.
Strong Financial Position
Moleculin Biotech has raised approximately $9 million in February 2025, leading to a combined cash balance of $13 million, extending runway into the third quarter of 2025.
Potential Game-Changer for AML Treatment
Annamycin has shown no drug-related cardiotoxicity and overcomes resistance to Venetoclax in AML. It is recognized as potentially the first non-cardiotoxic anthracycline, with experts acknowledging its significance.
Pipeline and Future Milestones
Moleculin is planning to publicly release data from MB107 in April and hopes to develop a pivotal investigator-initiated trial in Europe later in 2025. The company is focused on operational execution and meeting its milestones.