Annamycin (MB-106) in combination with Cytarabine - (Ara-C, MIRACLE)

July 31, 2026: Moleculin Biotech (NASDAQ: MBRX) reported updated preliminary blinded Part A results from the pivotal Phase 2/3 MIRACLE trial (MB-108) of Annamycin plus cytarabine (AnnAraC) in relapsed/refractory acute myeloid leukemia. Among 62 evaluable patients, blinded complete remission (CR) was 24% and composite complete remission (CRc) was 37%. In the subgroup of 30 patients previously treated with a venetoclax-based regimen, CR was 23% and CRc was 37%, similar to the overall blinded population.

The company said the analysis remains blinded and includes control-arm patients, so it is not directly comparable with the June 2026 interim unblinded analysis at n=45, where CRc was 50% and 57% in the two Annamycin arms versus 29% for control; CR was 43% and 36% versus 12% for control. Across blinded analyses at 30, 45, and 62 evaluable patients, CRc remained about 37% to 40%.

Enrollment has reached 74 of 90 patients in Part A. Moleculin expects the 90th patient to be treated in September 2026, with comprehensive unblinded Part A results expected in the December 2026 to February 2027 timeframe. The company also reported continued no evidence of cardiotoxicity based on ejection fractions and adverse events.