Core Insights - Annamycin shows significant activity in overcoming resistance to Venetoclax in acute myeloid leukemia (AML), with a 60% complete remission (CR) rate in patients previously treated with Venetoclax regimens, which is over four times higher than historical rates [1][2][4] Company Developments - Moleculin Biotech, Inc. is advancing Annamycin in a Phase 3 pivotal trial named MIRACLE, targeting relapsed or refractory AML patients, with patient treatment expected to begin in Q1 2025 [6][9] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML, as well as Orphan Drug Designation from the European Medicines Agency [7] Clinical Trial Results - Preliminary data from the MB-106 trial indicate a median overall survival of 11.6 months for subjects receiving Annamycin plus Ara-C as second-line therapy, and 9.1 months for those with a wider range of prior therapies [4][6] - The CR/CRi rate for patients treated with Annamycin in the MB-106 trial was reported at 60%, significantly higher than the 12.5% rate for standard salvage therapy in similar patient populations [2][4] Expert Commentary - Experts emphasize the need for better treatment options for AML patients who relapse after Venetoclax, highlighting Annamycin's potential to improve outcomes for these high-risk patients [2][5]
New Findings Show Moleculin's Annamycin Overcomes Resistance to Venetoclax in AML