PIPELINE

Advancing ecological medicines to treat severe and very severe diseases to fundamentally change clinical practices

Our mission is to treat iatrogenic dysbiosis related diseases by using the clinical promise of Fecal Microbiota Transfer beyond Clostridium difficile. Our GMP platform, the first to be validated and operated in Europe, allows us to move quickly into clinics as few clinical (Human) trials are currently underway for our investigational therapeutics.

Below is a list of clinical trials run by MaaT Pharma. Links to the study database on www.clinicaltrials.com are included below to provide you with more information.

 

Number of trials authorized 5
Number of included patients 160

What are Hematological malignancies?

They are rare cancers (aka blood cancers) that affect the blood, bone marrow, lymph and lymphatic system. These cancers are subdivided according to which type of blood cell is affected:

 Lymphoblastic or lymphocytic: a malignancy in the lymphoid lineage that produces white blood cells such as T and B lymphocytes. Examples include acute lymphoblastic leukemia, chronic lymphocytic leukemia, Hodgkin’s and non-Hodgkin lymphomas and multiple myeloma.

 Myelogenous or myeloid: a malignancy in the myeloid lineage that includes precursor cells to red blood cells, platelets and white blood cells. Examples include acute myelogenous leukemia, chronic myeloid leukemia, myelodysplastic syndromes.

The classification also includes how quickly the disease develops and worsens (acute vs chronic).

 For example, there are 4 major types of leukemia:
 Acute Lymphocytic leukemia
 Chronic Lymphocytic leukemia
 Acute Myeloid Leukemia
 Chronic Myeloid Leukemia

These diseases are increasingly found in patients aged 65 and over. The survival of these conditions including those deemed incurable and quality of life of people with the disease have been improved in recent years.

What is the worldwide estimated incidence and mortality (2012) ? 

    Incidence (% all cancers)         Mortality (% all cancers)
Leukemia 351 965 (2.5%) 265 471 (3.2%)
Hodgkin’s lymphoma 65 950 (0.5%) 25 469 (0.3%)
Non-Hodgkin’s Lymphoma 385 741 (2.7%) 199 670 (2.4%)
Multiple myeloma 114 251 (0.8%) 80 019 (1.0%)

Source – globocan.iarc.fr / 2012

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Acute Myeloid Leukemia Program - ODYSSEE

 

Objectives Status
Efficacy of autologous FMT in:
 Dysbiosis correction
 Eradication of multi-drug resistant bacteria in patients with acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (HR HDS) undergoing chemotherapy and antibiotherapy
Intermediary results presented during the ASH congress in 2017
› 2 positive DSMB (Data Safety Monitoring Board)
› 25 treated patients

 

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Graft verus Host Disease Program - HERACLES

 

Objectives Status
› Evaluation of Complete response or Very Good Partial Response of steroid refractory gastro intestinal acute Graft-versus-Host Disease (aGVHD) treated with allogenic Fecal Microbiota Transfer (FMT) › First Patient In expected soon

 

The most important reservoir of microorganisms in our environment is our body itself with billions of bacteria and other organisms present in our gut. Most of these organisms are harmless and beneficial to our health thanks to thousands of years of evolution. Nevertheless, this represents a very important source of microorganisms that can potentially be trans-located to other tissues/people and become pathogens. These organisms are called pathogens as they are the causative agents of a disease.

What are Infectious Diseases?

Infectious diseases are disorders caused by micro-organisms such as bacteria, viruses, fungi or parasites.

The consequences of these infections are various disorders of the infected organs causing them to stop functioning properly.
In addition to the deleterious impact of pathogens’ toxins, the host organism responds to the pathogen with a variety of strategies that aim to tolerate or fight the agent, control it, and finally clear it. The host response is organized by the immune system and may be, in some situations, so powerful that the inflammation reaction damages its own tissues and organs, potentially leading to a disease also associated with the term “sepsis”.

The most valuable medical treatment when facing a bacterial infection is by far the use of antibiotics. Nevertheless, antibiotics that go into the systemic circulation or go through the digestive tract certainly have a direct impact on the gut microbiota.

MaaT Pharma is working on two specific indications in infectious diseases in order to investigate the potential benefit of restoring the gut microbiota after an intense antibiotherapy.

Firstly, Bone and Joint Infections (BJI) present high investigation potential, due to the long-term antibiotherapy that the standard of care guidelines recommend. We are finalizing a study of the gut microbiome, before and after a 6 to 12 week antibiotic course, that aims to eradicate the pathogens present in the inflammatory tissue of prosthesis or osteosynthesis infected patients.

Secondly, we have have started a proof of concept clinical trial, aiming to treat patients admitted in Intensive Care Units (ICU). ICU patient’s complications are notably due to multiple infections with high risks of sepsis and are heavily treated with antibiotics. Fecal Microbiota Transfer is a promising new approach in preventing pathogens and drug resistance carriage in the large intestine of very susceptible patients.

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Bone and Joint Infections Program - OSIRIS

 

Objectives Status
› Establish the impact of intense antibiotherapies on the gut symbiosis
› Explore three types of BJI: prosthesis-related, relative or native osteosynthesis
› Evaluate the potential benefit of FMT in the BJI indication
› Recruitment ended, 62 inclusions in 5 French centers
› Last visit of Last Patient, March 2018
› 1 poster presentation at ECCMID April 2018

 

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Intensice Care Unit Program - HAPY3

 

Objectives Status
› Proof of concept to investigate feasibility and safety of FMT treatment in ICU admitted patients
› 10 inclusions with one FMT treatment
 2 patients treated
› No related adverse events reported yet

COLLABORATION

Partnering with MaaT Pharma to accelerate the access of our drugs to Patients

Right from the start, we have been working closely with researchers, academics, hospitals and private companies to resolve strategic medical and scientific questions. As we have grown and developed proprietary platforms and technologies, we’re expanding our network and are looking into entering additional partnerships using MaaT Pharma’s proprietary technology.

Feel free to reach out to us if you work in the field of treating iatrogenic modification of the Gut Microbiota dysbiosis (antibiotics, chemotherapies, stem cell transplantation conditioning) in hematologic malignancies, or other life-threatening situations as well as immuno-oncology.

For more information please contact us at: collaborations@maat-pharma.com

+33 (0)4 28 29 14 00