(RTTNews) - Moleculin Biotech, Inc. (MBRX), a late-stage pharmaceutical company, has announced the initiation of its Phase 3 MIRACLE trial for Annamycin, a next-generation anthracycline, in combination with cytarabine (AnnAraC) for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML).
The company has received US Institutional Review Board (IRB) approval to begin dosing patients in this pivotal trial, which will evaluate the safety, efficacy, and optimal dosing of Annamycin.
The MIRACLE trial, a global multicenter study, will assess Annamycin's performance in two dose cohorts (190 mg/m2 and 230 mg/m2).
Preliminary data from an earlier Phase 1B/2 trial showed promising results, including a 60% complete remission (CR/CRi) rate in patients who relapsed after or were refractory to Venetoclax-based therapies.
These results significantly outperform other major treatments currently available for AML.
Moleculin expects to reach an initial unblinded data readout in late 2025, with full recruitment and additional interim data expected in 2026.
The company is optimistic about Annamycin's potential to address the high unmet need in AML and advance its goal of delivering transformative therapies to patients with hard-to-treat cancers.
Moleculin is also advancing other therapeutic programs, including a treatment for soft tissue sarcoma lung metastases, and anticipates significant milestones in the coming years.
As of September 30, 2024, the Company had cash and cash equivalents of $9.4 million and believes that the existing cash and cash equivalents as of September 30, 2024, will be sufficient to fund planned operations into the first quarter of 2025.
Currently, MBRX is trading at $1.78 up by 1.14%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
