Moleculin Biotech disclosed that 60 % of the 45‑subject target for the first interim unblinding of its MIRACLE trial has consented, meaning 27 patients have entered the study. The company expects to complete treatment of these 27 patients in the first quarter of 2026, positioning the early safety and efficacy readout for the adaptive Phase 2B/3 study. The milestone is a key de‑risking event that will inform future regulatory submissions and potential partnership discussions.
The MIRACLE trial evaluates Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia. Annamycin has received FDA Fast Track and Orphan Drug designations for AML, and the trial’s adaptive design allows an early unblinding of data after 45 patients, with a second unblinding projected for the first half of 2026. This structure is intended to accelerate the development timeline while maintaining rigorous safety oversight.
Moleculin’s chief executive, Walter Klemp, noted that enrollment at several European sites has been slowed by bed shortages, and that treatment of new patients may decelerate during the holiday season. Despite these headwinds, the company reports strong momentum and investigator enthusiasm, and it plans to continue recruiting beyond the initial 45‑patient cohort to maintain the trial’s pace.
The enrollment update signals that the company is on track to de‑risk its lead program, a critical factor for a clinical‑stage biotech with no revenue and growing losses. Successful early readouts could unlock additional financing, support regulatory filings, and enhance the company’s attractiveness to strategic partners. Moleculin has indicated that it will need significant additional capital to complete the trial and move toward commercialization.
Market reaction to the update has been mixed. H.C. Wainwright reiterated a “Buy” rating on Moleculin, citing the enrollment progress as a positive development, while TipRanks’ AI analyst “Spark” maintained a neutral stance, reflecting the company’s high‑risk financial position despite the clinical milestone. The differing views underscore the balance between clinical promise and financial uncertainty in the biotech sector.
Beyond AML, Moleculin is exploring Annamycin for pancreatic cancer and has other candidates such as WP1066 and WP1122 in development. The company’s financial runway remains limited, and it has signaled a need for additional financing to sustain the trial and future programs. The enrollment update, however, provides a tangible step forward in a program that could ultimately offer a safer and more effective treatment option for patients with relapsed or refractory AML.
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