Moleculin Biotech reports preliminary data on 2023-end annamycin clinical trials

Moleculin Biotech announced 2023 year-end Annamycin clinical trials preliminary data and 2024 expectations for multiple data readouts and a transition to pivotal Phase 2B/3 clinical studies. The company is currently conducting its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy. The company has also begun recruiting 1st line subjects into this trial. The company continues to treat subjects in the Phase 2 portion of the study. Among subjects who had an evaluable post treatment bone marrow biopsy, or who dropped out due to an adverse event, there have been 6 complete responses and 1 complete response with incomplete recovery of the intent to treat subjects and 46% CR’s and 54% CR/CRi’s of the subjects treated. The company does not expect the addition of a cohort to delay its End of Phase 2 Meeting with the FDA. The first CR subject was treated in February 2023. The company has not been notified of any relapses to date, indicating significant durability of the CRs. There continues to be no evidence of cardiotoxicity. Moleculin expects to complete recruitment and report topline data in 1H 2024, if not by the end of Q1. In the Phase 2 portion of its U.S. Phase 1B/2 clinical trial evaluating Annamycin as monotherapy for the treatment of soft tissue sarcoma lung metastases, preliminary data from the Phase 1B portion of the study showed median PFS for 67% of the Phase 1B subjects of over 2 months and median overall survival of 11.3 months. Phase 1B subjects with less than or equal to 2 prior treatments and treated at the recommended Phase 2 dose or lower demonstrated a higher percentage of subjects with PFS of 2 months or greater at 78%. The company believes that the data will be similar to or better than the Phase 1B portion of the study.