MaaT Pharma is racing its microbiome therapy into a late-phase cancer clinical trial. Rather than take the current phase 1b to its planned conclusion, MaaT is wrapping the trial up early to accelerate its push into a larger study of acute myeloid leukemia (AML) patients.
The drug, MaaT033, is designed to restore the functionality of the gut ecosystem, thereby improving the clinical outcomes and controlling the adverse events associated with existing anti-cancer therapies. MaaT set out to evaluate the microbiome engraftment of five different doses of MaaT033 in AML patients in a phase 1b study but has decided it has already seen enough to advance the oral, off-the-shelf therapy.
“With a very satisfactory safety profile and very promising engraftment data in the first four cohorts of this trial, we believe we have the appropriate amount of data in hand to confidently move forward with MaaT033’s clinical development, without testing the highest planned dose of nine capsules a day,” John Weinberg, M.D., chief medical officer at MaaT, said in a statement.
MaaT found bacteria indicative of engraftment in the guts of patients, regardless of the dose given. After seeing engraftment across the 21 patients who received up to three capsules of MaaT033 a day for 14 days in the first four dose cohorts, MaaT chose to finish the study early.
Work is now underway to evaluate the full data from the study and move MaaT033 into a phase 2/3 trial. The full data are due in the first half of the year, with the initiation of the phase 2/3 study set to follow in the back half of 2022.
The phase 2/3 will show whether MaaT033 can live up to expectations. MaaT sees the drug candidate as a way to boost survival in patients receiving allogeneic hematopoietic stem cell transplantation, pointing to evidence that higher gut microbiome diversity is associated with better outcomes to make its case.