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Moleculin Biotech Secures Georgian Regulation Agency for Medical and Pharmaceutical Activities Approval For Phase 2B/3 MIRACLE AML Trial; European Medicines Agency Boosts Profile As Enrollment Expands To 30+ Sites With Data Readout Expected In 2H 2025

Benzinga·07/09/2025 12:37:02
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Secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia for Phase 2B/3 MIRACLE trial 

Recent EU approval from the European Medicines Agency (EMA) boosts trial profile

Enrollment in Part A of MIRACLE reaches seven subjects treated and one additional subject in screening

16 additional clinical sites in Europe and the US expected to begin recruitment by the end of August; building to an expected 30 plus sites for Part A of MIRACLE

Anticipated data readout of Part A remains in 2H 2025

HOUSTON, July 09, 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 Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in the country of Georgia 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") 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). 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. Additionally, the Company expects the first patient to be treated in Georgia to occur by the end of August, if not sooner.