1. Enrollment for MIRACLE trial has increased to 78%, up from 60%. 2. The first interim data unblinding expected in Q1 2026. 3. Annamycin shows potential to improve AML treatment outcomes. 4. European bed shortages affecting early enrollment are improving. 5. Moleculin requires additional financing to continue clinical trials.
FAQ
Why Bullish?
The increase in enrollment and upcoming data unblinding could spark investor interest. Past examples show that positive trial updates often correlate with stock price surges for biotech companies.
How important is it?
The article discusses significant trial progress and positive developments that are likely to attract investor attention and raise expectations for MBRX.
Why Short Term?
The upcoming unblinding is imminent and may influence market perception soon. Typically, such events can lead to quick market reactions depending on trial results.
Moleculin Biotech Achieves Milestone in Pivotal Phase 3 AML Trial: MBRX Update
HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc. (Nasdaq: MBRX) has announced significant progress in its pivotal Phase 2B/3 “MIRACLE” study, aimed at evaluating the efficacy of Annamycin in combination with cytarabine for treating adult patients with relapsed or refractory acute myeloid leukemia (R/R AML). The Company reports an increase in enrollment, with 78% of the target subjects consented as of December 3, 2025, marking an increase from 60% reported in November.
Enrollment Update and Trial Overview
The MIRACLE trial targets a total of 45 subjects for the initial interim unblinding of data. This increase in consented participants demonstrates robust interest and participation from investigators across seven countries. The ongoing recruitment is crucial for the trial's timeline, with expectations to complete treatment for the first 45 subjects by the end of Q1 2026.
- Consent Rate: 78% of target subjects consented
- Previous Month's Consent: 60%
- Target for Unblinding: 45 subjects
- Completion Expectation: Q1 2026
CEO's Insights on Trial Progress
Walter Klemp, Chairman and CEO of Moleculin, expressed optimism regarding the trial's progress. “We are quickly approaching our first unblinding milestone, and the increase in subjects consented within just one month is highly encouraging,” said Klemp. He emphasized the improving enrollment conditions in Europe, previously hindered by complications such as bed shortages. These developments align with the Company's goal of determining Annamycin's potential as a safer and more effective treatment for AML.
Understanding the MIRACLE Trial
The MIRACLE study, named for Moleculin’s approach to R/R AML, is a Phase 2B/3 global, multi-center, randomized, double-blind, placebo-controlled trial. The trial design is adaptive, leveraging data insights from the 2B portion to inform the Phase 3 portion, combining to measure the primary efficacy endpoint effectively.
The first unblinding will occur after treating 30 subjects with Annamycin (administered in two dosages) alongside HiDAC, compared to 15 subjects receiving HiDAC plus a placebo. This early unblinding will offer preliminary insights into efficacy and safety.
Next Steps and Future Prospects
Moleculin plans to continue recruitment to reach a total of 90 subjects by the conclusion of Part A of the trial in the first half of 2026. Following the unblinding of the first 45 subjects, the data collected will guide future dosing decisions for Part B of the MIRACLE trial.
For additional updates on the MIRACLE trial, interested parties can refer to clinicaltrials.gov with identifier NCT06788756, or to the EU registry at euclinicaltrials.eu with identifier 2024-518359-47-00.
About Moleculin Biotech and Annamycin
Moleculin Biotech, Inc. focuses on developing treatments for hard-to-treat tumors and viruses. The Company’s leading candidate, Annamycin (naxtarubicin), has been granted Fast Track and Orphan Drug Designation by the FDA for treating R/R AML. Furthermore, Annamycin holds patent protection until 2040, with potential extensions through 2045.
Forward-Looking Statements
This press release includes forward-looking statements regarding the timing of trial completion and the financial needs for continued clinical development. These statements carry inherent risks and uncertainties, particularly concerning the Company's ability to secure funding as needed.