Moleculin Biotech doses first patient in Phase 3 MIRACLE trial

Moleculin Biotech (MBRX) announced the first patient has been dosed in its Phase 3 pivotal trial evaluating Annamycin in combination with Cytarabine for the treatment of AML patients who are refractory to or relapsed after induction therapy. This Phase 3 “MIRACLE” trial is a global approval trial, including sites in the US, Europe and the Middle East. “The start of patient dosing represents a huge milestone for Moleculin and importantly, the AML community,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “Our team remains focused on bringing clinical sites online in the U.S., Europe and Middle East and enrolling patients to build on this momentum. With the progress made to date, we expect to unblind preliminary data from the first 45 subjects in the second half of this year, a near-term, potentially value-driving milestone that will provide key insight as we continue to advance Annamycin’s development towards approval.”