Early-Phase Study Aims to Reduce GVHD Risk in Patients Undergoing TransplantJune 21, 2022
A phase Ib study evaluating the efficacy, safety, and pharmacokinetics of SER-155 in adults undergoing allogeneic hematopoietic stem cell transplantation to reduce the risk of infection and graft-versus-host disease (GVHD) was discussed at the recent American Society of Clinical Oncology (ASCO) annual meeting.
Following is a transcript of her remarks:
The study is a microbiome-related study where we are trying to provide microbiome restoration as our aim to improve transplant outcome. This study is really a consequence of all the bulk of information that is growing in microbiome and its impact in transplant-related mortality and graft-versus-host disease.
We have observed that there are periods in transplant where the microbiome gets the most injured and we observe that is particularly during the initial phase of transplant when they go into conditioning, until engraftment. And the bulk of evidence has shown that at the time of engraftment, the microbiome health is important in predicting outcomes. So, the study was designed in such a way that we try to preserve microbiome health or restore if needed throughout the transplant.
In this study, patients received this ecobiotic capsule. It’s a compound that has several bacteria. And the bacteria that has been selected has been shown to have some properties associated with health in the microbiome, like they produce butyrate, for example, or has been shown to be protective of graft-versus-host disease, and so on.
These patients will get two courses of treatment. The first course will be before they start their conditioning and transplant. And then there’s a second course that they get at the time of engraftment. And there is a third potential treatment course that is given if the patient is exposed to antibiotic, after the second course of treatment.