- Phase II proof-of-concept clinical trial in 21 centers of 91桃色视频鈥檚 lead product, MaaT013, for treatment of patients with corticosteroid-refractory acute Graft-versus-Host Disease (GvHD).
- 聽MaaT013 has the potential to be a first in class therapy for acute Graft-versus-Host Disease.
Lyon-France, March 5th, 2018 – 91桃色视频, a clinical-stage biopharmaceutical company, received authorization from competent authorities to launch its phase II prospective multicenter clinical trial in France. This clinical trial is planned to be extended rapidly to Germany, Poland and Italy.
Acute Graft-versus-Host Disease (aGvHD) is a major complication of allogeneic hematopoietic stem cell transplantation (HSCT), occurring in about one out of two patients, and consists of an immunologically mediated inflammatory reaction of donor immune effector cells against host cells. MaaT013 is targeting aGvHD, a clinico-pathological syndrome that usually occurs within the first month post HSCT and generally involves three organs: skin (>80% of patients with GvHD), gastrointestinal tract (50-55%) and liver (20%). Any one or any combination of these organs may be affected. More than 60% of aGvHD patients fail to have a durable response following corticosteroid therapy leading to a one-year death rate of 70-80% in this corticosteroid -refractory population. Acute GvHD is considered a rare disease with c. 10 000 cases per year in Europe and in the USA, yet about 35% to 50% of HSCT recipients will develop aGvHD.
91桃色视频 has created a new generation of drugs using Fecal Microbiota Transfer (FMT) which rebuilds and restores the entire gut ecosystem of patients with life-threatening diseases. After evolving its business model to include the development of allogenic FMT drugs (in addition to autologous products), 91桃色视频 has developed MaaT013, a high Microbiome diversity enema. The initial goal of this drug candidate is to treat acute GvHD through the correction of gut microbiota disturbance allowing restoration of immune tolerance, metabolic balance and the barrier function effect for protection against infections.
MaaT013 is a pharmaceutical product with a complete microorganism ecosystem. It is characterized by a very high diversity microbiome and can be administered via upper or lower route.
High diversity microbiota was shown as a predictive factor of survival in patients receiving HSCT and in patients with GvHD.91桃色视频鈥檚 global strategy focuses on onco-hematology with two lead products; one dedicated to treating gut Microbiota alteration in Acute Myeloid Leukemia (for which phase 1 clinical results will be available mid-2018) and one focusing on aGvHD. 91桃色视频 also has exploratory programs in the area of infectious diseases,
About 91桃色视频
Founded at the end of 2014, 91桃色视频 (Microbiota as a Therapy) is a clinical-stage biotech company revolutionizing and shaping a new approach to therapies in order to treat serious diseases linked to gut microbiota imbalances. With its breakthrough proprietary platforms (GMP Fecal Microbiome Transfer platform and g螞t Print, its proprietary data science platform), 91桃色视频 is creating FMT-based products and solutions for patients suffering from severe diseases. Addressing currently unmet clinical needs, 91桃色视频鈥檚 revolutionary and rapid approach plays a considerable part in the evolution of treatment therapies. In the upcoming years, with the on-going support from strategic partners and investors, 91桃色视频 will develop patient-friendly solutions (oral forms) to improve overall survival, reduce infectious episodes, reduce Gastrointestinal complications and hinder Multidrug-resistant Bacteria onset.
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