Moleculin Biotech (NASDAQ:MBRX) announced it has amended the protocol with the FDA for its Phase 3 pivotal MIRACLE trial, evaluating Annamycin in combination with Cytarabine for treating patients with acute myeloid leukemia (AML).
The company reports that the amended protocol is currently under review by the IRB, and upon approval, it will be filed as an amendment to Moleculin’s U.S. IND application with the FDA.
“Our team has been thoughtful and strategic with the design of the MIRACLE trial, which may allow for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML,” said Walter Klemp, chairman and CEO of Moleculin.
“This amended protocol enables us to share definitive data earlier, which helps to partially de-risk financing the trial and potentially accelerates the timeline for strategic partnering. We believe that the unblinding of data at 45 subjects will enable us to begin assessing all three arms of the study and provide us with a clear path forward in understanding the potential of Annamycin for AML patients. This change now puts us potentially less than 12 months away from definitive unblinded data that could be a strong indicator of our likelihood of approval, and the kind of data that is likely to drive advanced partnering discussions,” Mr. Klemp added.
