Microbiome is a fascinating field. Over the last decade, we are able to demonstrate that there is a link between the microbiome diversity and the patient outcome after hematopoietic cell transplantation. But it’s not only a link. Now we have also some evidence that prove that there is a pathophysiological link between the microbiome composition and the graft-versus-host disease pathophysiology...
Microbiome is a fascinating field. Over the last decade, we are able to demonstrate that there is a link between the microbiome diversity and the patient outcome after hematopoietic cell transplantation. But it’s not only a link. Now we have also some evidence that prove that there is a pathophysiological link between the microbiome composition and the graft-versus-host disease pathophysiology. So this suggests, or more than suggests, it shows that if we manipulate the microbiome, we may achieve some efficacy to prevent or to treat graft-versus-host disease. I am going to present tomorrow a key abstract. This is a result of the ARES Phase III study. That is a study that evaluates microbiome therapy, a product that is called MaaT013, for the treatment of patients with GI-acute graft-versus-host disease that failed both steroids but also ruxolitinib. So this is some very severe patients with GI involvement that failed two lines of treatment and that received MaaT013 as a third-line treatment. And in fact, the patients received three consecutive FMT, fecal microbiota transfer, using this product MaaT013. And we achieved, with these treatments, a response rate in the GI tract of 62%. But when we look at the overall response, taking into account also the upper GI, the skin and the liver, the overall response rate is at 64%. And these responses were sustained at day 56, but only at three months. And I think we have to have some long-term effect on that we have a systemic effect. And we have an overall survival in the whole cohort of 54%, and when we compare it with some historical control, it’s only 20%. So it’s truly amazing to be able to achieve such a result, and we are very excited to share this Phase III study on behalf of all the co-investigators.
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