MaaT Pharma has dosed the first subject in the Phase IIb PHOEBUS clinical trial of its drug candidate, MaaT033, in blood cancer patients who are receiving allogeneic haematopoietic stem cell transplant (allo-HSCT).
The global, multicentre, double-blind, placebo-controlled, randomised trial is designed to assess the efficacy of MaaT033 as an adjunctive treatment to boost overall survival (OS) at 12 months.
It will be carried out at up to 56 trial sites and is anticipated to enrol 387 subjects.
MaaT Pharma obtained regulatory approvals in France and Germany for the trial, which will subsequently be launched in further countries.
OS is the primary endpoint of the trial and will be assessed in late 2026.
The tolerability and safety before and after allo-HSCT and assessing engraftment of beneficial microbial species following dosing with MaaT033 will be analysed as secondary endpoints.
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An oral microbiome ecosystem therapy obtained from the donor, MaaT033 comprises anti-inflammatory Butycore species. It received orphan drug designation from the European Medicines Agency (EMA) in August this year.
MaaT Pharma CEO and co-founder Hervé Affagard said: “Today marks a significant milestone for us as our second product, MaaT033, enters Phase IIb clinical trials in allo-HSCT.
“The opportunity to offer patients a capsule that can be taken at home not only furthers our overall mission to improve patient survival in multiple situations but also reinforces our leadership in the field, as we believe this programme is currently the most advanced in the microbiome/haemato-oncology field.”