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Moleculin Biotech Receives EMA Approval For Clinical Trial Application To Conduct Pivotal Phase 2B/3 AnnAraC Clinical Trial

Benzinga·05/12/2025 12:42:12
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Adds nine additional countries to the Company's ongoing pivotal Phase 3 trial; Authorization granted in all EU countries requested

Enrollment and dosing underway in Phase 3 clinical trial (the "MIRACLE" trial) evaluating Annamycin for the treatment of R/R AML; Interim data readout expected in the second half of 2025

Subjects targeted for the "MIRACLE" trial include venetoclax regimen failures where outcomes with currently available therapies are considered dismal

HOUSTON, May 12, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, today announced that the European Medicines Agency (EMA) has approved its Clinical Trial Application (CTA) to conduct its pivotal Phase 2B/3, multi-center, randomized, double-blind, placebo-controlled, adaptive design study 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"). The study is for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML) and is approved in all nine countries submitted in the European Union (EU). This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a global approval trial, including sites in the US, Europe and the Middle East.