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Moleculin Announces Plans for MIRACLE Phase 3 Pivotal Trial
Based on an encouraging discussion in the End of Phase 1B/2 Meeting with FDA the Company plans to: Proceed with a pivotal, adaptive Phase 3 clinical trial
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"Based on an encouraging discussion in the End of Phase 1B/2 Meeting with FDA the Company plans to:\nProceed with a pivotal, adaptive Phase 3 clinical trial (the \"MIRACLE\" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML;\nRun such future studies globally and in the US above the lifetime maximum allowable anthracycline dose; and\nProvide the FDA with additional data supporting the selection of the optimal dosing level via the adaptive design in the MIRACLE trial\nHOUSTON, Aug. 1, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (\"Moleculin\" or the \"Company\"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the positive discussion in and outcome of its End of Phase 1B/2 (EOP1B/2) meeting with the US Food and Drug Administration (FDA) supporting the advancement of Annamycin in combination with Cytarabine (also known as \"Ara-C\" and for which the combination of Annamycin and Ara-C is referred to as \"AnnAraC\") to a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 \"MIRACLE\" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be a global trial, including sites in the US.\n\n \n \n \n \n \n \n\n \n\"We thank the FDA's Divisions of Hematologic Malignancies I and Cardiology and Nephrology, as well as related divisions, for a very constructive EOP1B/2 meeting and for their valuable feedback. Armed with this, we are now able to finalize plans for a pivotal approval pathway in AML,\" commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. \"Importantly, consistent with the FDA's recommendations, the adaptive Phase 3 trial will rely solely on CR (complete remission) at day 30 as the primary endpoint versus placebo, a standard we are confident Annamycin will meet and that provides an opportunity for accelerated approval.\" \nMr. Klemp continued: \"We now also have additional confidence that our planned pivotal trial should be able to generate data supportive of a true value inflection point for shareholders in a timely manner. We plan to utilize a double-blind, placebo-controlled design, where the control arm is...