So we performed a Phase II study to evaluate fecal microbiota transplantation using MaaT013. That is a biotherapeutic that is provided by a pool of healthy donors, so we take some stool of healthy donors. We have already available FMT product and we are able to treat the patients as soon as possible when we need to treat it. We evaluated this treatment in patients with steroid resistance, GI acute graft-versus-host disease and we performed three FMT one week apart, and we evaluated the response rate at day 28...
So we performed a Phase II study to evaluate fecal microbiota transplantation using MaaT013. That is a biotherapeutic that is provided by a pool of healthy donors, so we take some stool of healthy donors. We have already available FMT product and we are able to treat the patients as soon as possible when we need to treat it. We evaluated this treatment in patients with steroid resistance, GI acute graft-versus-host disease and we performed three FMT one week apart, and we evaluated the response rate at day 28. 24 patients were included in this clinical trial. The overall response rate at day 28 was 38%, including five patients in complete response, two patients in very good partial response and two partial response. We evaluated the best GI response, it was higher, it was 54%, including 38% of complete response. This translated into a good overall response rate for this very high-risk population, since it was 29% at six months and 25% at 12 months.
Interestingly, if we focus on the responding patients the overall response rate at 12 months was 44%. Yes, we think this is a promising treatment. Here was a result of the Phase II clinical trial. We also evaluated these drugs into compassionate use program in France and we treated 52 patients, and we have some even better results since the overall response rate reached 58% at day 28, and the best of our response rate was 77%. This translated into overall survival of 38% at 12 months, and almost 60% in responding patients at 12 months. So we think that fecal microbiota transplantation, through the MaaT013 or any other product that is available in your country, is a very promising treatment in this setting. Of course, we have other promising treatments for steroid-resistant acute graft-versus-host disease, such as ruxolitinib, that is approved in the US now and maybe in Europe. So we think that now these drugs may be used in patients that are both refractory to steroids and to ruxolitinib, and will be used as a third-line treatment and the next clinical trial will evaluate these drugs in this setting.
