Policy & Regulation
Moleculin announces positive preliminary interim data from AML Clinical Trial of Annamycin in combination with Cytarabine
17 June 2024 -

Moleculin Biotech, Inc., (Nasdaq: MBRX), a Texas-based clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumours and viruses, reported on Friday additional efficacy findings from the company's ongoing Phase 1B/2 (MB-106) clinical trial evaluating 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 subjects with acute myeloid leukaemia (AML).

The preliminary data was presented at the European Hematology Association (EHA) 2024 Hybrid Congress. The company also hosted a data presentation to leading AML experts as part of a KOL meeting held in conjunction with EHA 2024 Congress.

To date, a total of 22 subjects have been enrolled (the Intent-to-Treat population, ITT), 20 (Lines 1st-7th) of whom have completed efficacy evaluations with 9 subjects (45%) achieving a composite complete remission (CRc or CR/CRi), consisting of 8 (40%) subjects with complete remission (CR) and one subject with complete remission with an incomplete recovery of peripheral blood counts (CRi), following treatment with AnnAraC. Efficacy outcomes for 2 additional subjects (enrolled and treated) are pending.

'We continue to be highly encouraged by the positive growing body of preliminary clinical data demonstrated by Annamycin in the treatment of patients with AML,' commented Walter Klemp, of Moleculin chairman and chief executive officer. 'While still preliminary, we believe the efficacy to date including the climbing durability of response demonstrated by AnnAraC in 2nd line patients continues to significantly exceed the performance reported by any drug currently approved for use in 2nd line AML. We are incredibly pleased with the progress of the trial and the data and continue to advance our preparations for an End of Phase 2 meeting with FDA.'