HOUSTON - Moleculin Biotech, Inc. (NASDAQ:MBRX), a clinical stage pharmaceutical company, announced preliminary clinical trial results for its lead drug candidate Annamycin, in combination with Cytarabine, for the treatment of Acute Myeloid Leukemia (AML).
The ongoing Phase 1B/2 trial has reported a complete response composite (CRc) rate of 60% in subjects receiving the treatment as a second-line therapy.
The trial, which includes subjects who have relapsed or are refractory to initial AML therapy, has shown that Annamycin, in combination with Cytarabine (referred to as AnnAraC), may offer a significant improvement over existing second-line treatments. According to the company, current therapies only yield a positive outcome for about 7% of the total AML population, potentially leaving a vast majority without effective treatment options.
Moleculin's data suggests that AnnAraC could more than double the number of second-line patients achieving a complete response. The company also highlighted that none of the 82 subjects across multiple Annamycin studies have shown signs of cardiotoxicity, suggesting a lower toxicity profile than traditional intensive AML therapies.
The company is preparing for an End of Phase 2 meeting with the FDA and anticipates starting a pivotal registration study as a second-line therapy in AML before the end of 2024. This could position AnnAraC for an accelerated approval pathway.
The current trial has enrolled 20 subjects, with 18 evaluable for the preliminary analysis. The study has recruited the desired number of second-line subjects to support the upcoming FDA meeting and may complete with fewer than the 28 subjects initially planned.
Moleculin hosted a conference call and webcast today to discuss these developments and the company's clinical and regulatory strategies moving forward. The company's lead program, Annamycin, is designed to avoid multidrug resistance mechanisms with minimal cardiotoxicity, targeting relapsed or refractory AML and soft tissue sarcoma lung metastases.
This update is based on a press release statement from Moleculin Biotech, Inc.
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