Moleculin Biotech reports Phase 2 interim data in STS and pipeline update

Moleculin Biotech announced recent activity, new positive data and expected near term milestones across its clinical development pipeline. "…Our team believes that the human activity demonstrated with our lead program, Annamycin, in two separate indications, normally treated with doxorubicin (or its equivalent), continues to support our expectation of generating pivotal data in 2023. Additionally, preliminary data continue to demonstrate a promising safety and efficacy profile with zero evidence of cardiotoxicity, as analyzed by our independent expert, which bolsters our confidence in Annamycin’s potential as we continue to advance development. Additionally, we are pleased with the rapid pace of enrollment in our Phase 2 STS lung metastases clinical trial that, we believe, has us on track to complete enrollment in the first half of 2023 and in a position to report topline data from this study in the second half of this year," commented Walter Klemp, CEO. "We are actively recruiting in three Phase 1b/2 clinical trials and expect to add more trials during the year. These three currently active clinical trials are open label and provide us with the opportunity to announce clinical activity as it is being demonstrated throughout 2023. Additionally, in February 2023, our externally funded Phase 1 clinical trial studying WP1066 for the treatment of pediatric brain tumors concluded, and we expect to have at least three externally funded Phase 1b/2 clinical trials for WP1066 in the treatment of GBM and other brain tumors in 2023, including another pediatric clinical trial, in the U.S. and, possibly, in Southeast Asia." Annamycin is the company’s 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. An independent expert has reported no signs of cardiotoxicity in the first 42 patients in the company’s three clinical trials. Annamycin is currently in development for the treatment of STS lung metastases and relapsed or refractory acute myeloid leukemia and the company believes the drug may have the potential to treat additional indications. The company is currently in the Phase 2 portion of its ongoing U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases. In this Phase 2 portion of the trial to date, Annamycin has demonstrated a preliminary response of 67% – 4 of 6 – of subjects showing SD through 2 or more cycles, with one subject continuing with the study drug. The company is currently conducting its Phase 1b/2 clinical trial evaluating Annamycin in combination with Cytarabine for the treatment of subjects with AML who are refractory to or relapsed after induction therapy.