October 7, 2025 — Leads & Copy — MaaT Pharma (EURONEXT: MAAT) announced that the independent Data Safety Monitoring Board (DSMB) has completed the second pre-planned safety interim analysis of the ongoing PHOEBUS trial. The Phase 2b randomized controlled trial is designed to evaluate the efficacy and safety of MaaT033 versus placebo in patients undergoing an Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT).
The DSMB reviewed unblinded safety data on 120 enrolled patients and monitored patients for 90 days after allo-HSCT. The DSMB recommended that the study continue as planned, having identified no safety concerns and no excessive mortality related to MaaT033 as of today.
Patient enrollment for the PHOEBUS trial is ongoing in France, Germany, Belgium, Spain, Netherlands and the United Kingdom. The trial is expected to enroll 387 patients and is set to be conducted in up to 60 clinical investigational sites (NCT05762211). Next steps include the routine DSMB review for ongoing safety for MaaT033, conducted every six months, with the next analysis expected for the first quarter of 2026.
Hervé Affagard, Chief Executive Officer and co-founder of MaaT Pharma, said the positive safety review for MaaT033 with the DSMB’s recommendation to continue the trial without modification marks a key milestone in its development. Affagard said the company remains fully committed to advancing this Phase 2b trial and to delivering a much-needed therapeutic option for patients fighting blood cancers and undergoing allo-HSCT.
MaaT033 is designed to reach an expanded patient population through its oral capsule administration that could address approximately 6.000 patients per year, with an estimated potential market of €500 million (EU5, US). By enabling outpatient use, MaaT033 also supports optimized patient care. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021.
Source: MaaT Pharma
