MaaT Pharma completes patient recruitment of its Odyssée clinical trial.
Within thirty months of its creation, Maat Pharma has reached the target number of patients to be treated in its first clinical trial, Odyssée. The biotech is testing the efficacy of its drug candidate, MaaT001.3, using Autologous Fecal Microbiota Transfer on patients suffering from Acute Myeloblastic Leukemia. The end of the recruitment phase positions MaaT Pharma as one of the most advanced companies in the promising Microbiome industry.
Lyon (France), 20th July 2017 – MaaT Pharma, a European MicrobioTech1 specialized in the development of innovative treatments based on intestinal microbiota in onco-hematology and infectiology, announces recruitment completion of its Odyssée study using MaaT001.3, an internally developed experimental drug.
The clinical study is a multi-centric trial conducted in France on patients with Acute Myeloblastic Leukemia (AML). These patients suffer from iatrogenic dysbiosis induced by chemotherapy and / or antibiotics. The candidate drug, MaaT001.3, is administered to patients once their treatment against leukemia has ended. Reconstitution of the intestinal microbiota is evaluated 10 days after the Autologous Fecal Microbiota Transfer (FMT), which is the primary endpoint of the Odyssée clinical trial.
Patient recruitment completed with promising preliminary results
Recruitment is complete and 25 patients have been treated since September 2016. The rapidity of recruitment testifies the interest of the medical community. Preliminary analyses indicate a structural and functional restoration of the host-microbiota symbiosis. In addition, the Data and Safety Monitoring Board validated the pursuit of the study based on available safety data. Odyssée will serve as the basis to launch an ambitious phase II clinical program already in preparation.
”"The trial is, to our knowledge, the largest European study on patients with Myeloblastic Acute Leukemia treated with a FMT product manufactured according to pharmaceutical standards”Hervé Affagard, CEO of MaaT Pharma.
"We believe that the positive results from our study could pave the way for the development of several FMT-based drugs for the treatment of different indications in onco-hematology."
Final results are expected in the last quarter of 2017. MaaT Pharma will be submitting an abstract for the annual meeting of the American Society of Hematology to be held in Atlanta in December 2017.
Microbiome research, an investment for the future
Recent findings in microbiome research are promising and open new therapeutic pathways for physicians and patients in infectious diseases, cancer, immuno-deficient diseases, obesity, autism, etc. In parallel with the increase in scientific publications, investments in biotech companies specialized in the microbiome have multiplied. For example, the United States chose to launch in 2016 “The National Microbiome Initiative” with a fund of more than $ 120 million for research. France also supports biotech companies like MaaT Pharma in this sector, through its PIA investment program. MaaT Pharma is the first MicrobioTech to use Fecal Microbiota Transfers (FMT) in patients suffering from Acute Leukemia.
Initially a pioneer in Autologous Fecal Microbiota Transfer, MaaT Pharma currently develops drug products using autologous and allogeneic microbiota. Driven by its exponential growth, MaaT Pharma has teamed up with Biocodex to develop an oral form of its drug. A step further towards industrialization of FMT for this microbioTech company, which has developed the first CE marked device for stool collection and dilution.
Founded at the end of 2014, MaaT Pharma (Microbiota as a Therapy) is a microbiome–based pharmaceutical company revolutionizing and shaping a selective approach to therapies in order to treat serious diseases linked to gut microbiota imbalances. MaaT Pharma is currently developing autologous (donor and patient being the same individual) and allogenic (donor based) FMT products for patients suffering from Acute Myeloblastic Leukemia, and bone and joint infections, to optimize chances of success of the harsh medical treatment used to combat such diseases. MaaT Pharma’s revolutionary and rapid approach plays a considerable part in the evolution of individual treatment therapies.
Thanks to the 16 million euros in funding, the company is increasing its partnerships with renowned institutions such as INRA, Institut Gustave Roussy, Bioaster, etc. In the coming months, MaaT Pharma will pursue its development programs and is preparing its next fundraising with the objective of launching an oral formulation of the FMT drug product by 2018 and a marketing authorization in 2022.
MaaT Pharma is backed by its investors who are experts in the Microbiome field and in technological developments: Seventure, CM-CIC Innovations, Biocodex and INRA.
For additional information, please visit www.maatpharma.com or follow us on Twitter @MaaT_Pharma.