- Moleculin said on Wednesday that it believes it is on track to treat the 45th subject in the first quarter of 2026, and an unblinding of data is expected thereafter.
- To date, 35 subjects have been treated and another 11 are in screening or identified.
- In the first 30 patients treated with Annamycin in the trial, the company reported a preliminary composite complete remission (CRc) rate of 40%.
Shares of Moleculin Biotech, Inc., (MBRX) rose 14% on Wednesday after the company said that it is on track to treat the 45th patient with Annamycin as part of its Miracle study.
The company is studying Annamycin in combination with cytarabine for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy.
To date, 35 subjects have been treated and another 11 are in screening or identified. Site investigators are continuing to identify additional subjects and once 45 subjects are treated, the company will make its first data reveal, it said.
Moleculin said on Wednesday that it believes it is on track to treat the 45th subject in the first quarter of 2026, and an unblinding of data is expected thereafter.
What Does The Data Show So Far?
In the first 30 patients treated with Annamycin in the trial, the company reported a preliminary composite complete remission (CRc) rate of 40%. Composite remission (CRc) is commonly used to measure early efficacy and safety of novel agents in clinical trials.
“The blinded efficacy rates we’re seeing in MIRACLE are exceptionally encouraging,” said Moleculin CEO Walter Klemp. “And, of course, this includes the control arm of cytarabine plus placebo, which suggests that the Annamycin results should be better.”
Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around MRX stock stayed within ‘bullish’ territory over the past 24 hours, while message volume rose from ‘normal’ to ‘high’ levels.
A Stocktwits user expressed optimism for the data unblinding. “If good, it will truly be explosive,” they wrote.
Another user expects good days ahead.
MBRX shares have lost about 89% over the past 12 months.
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