Clinical-stage biotechnology company MaaT Pharma (Euronext Paris:MAAT) announced on Tuesday that the independent Data Safety Monitoring Board (DSMB) has completed its second planned safety interim analysis of the Phase 2b PHOEBUS trial evaluating MaaT033 in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

The DSMB found no safety concerns or excess mortality associated with MaaT033 and recommended that the study continue as planned.

The unblinded review included data from the first 120 enrolled patients, with 60 receiving MaaT033, and covered a 90-day monitoring period post-transplant. The results confirmed a favourable safety and tolerability profile consistent with prior analyses.

Routine safety reviews are conducted every six months, all of which have supported continued study operations without protocol modifications. The PHOEBUS trial, the largest randomised controlled microbiome therapy study in oncology, is ongoing across multiple European countries and aims to enrol 387 patients.

MaaT033, an oral microbiome-based therapy with Orphan Drug Designation from the European Medicines Agency, targets an estimated annual market of EUR500m across the EU5 and the United States.