The News:

A clinical trial run by Maat Pharma SA (Lyon FRA) has shown that restoring the Microbiome of patients undergoing chemotherapy has potential to improve the outcome of patients with the blood cancer acute myeloid leukemia (AML).

The microbes living in our gut can have a big influence on the success of cancer treatments. Some microorganisms are known to render cancer drugs ineffective, whereas others are actually necessary to make these drugs work. The harsh chemotherapy and antibiotic regimens that cancer patients undergo can kill many beneficial microorganisms. French biotech MaaT Pharma aims to improve the chances of recovery for AML patients by ensuring they have a healthy microbiome, Clara Rodríguez Fernández reports for Labiotech.

The 25 patients enrolled in the Phase 1b/2a trial were given a transplant of their own gut microbiome in between two rounds of chemotherapy. After the second chemo, the patients had 90% of their original microbial species restored, and the samples had 43% less antibiotic resistance genes. The treatment also reduced inflammation in the gut, along with reduced numbers of bacteria that are linked to inflammation.

With this proof that microbiome therapy can indeed help restore a healthy gut microbiome, MaaT Pharma is now working on refining its treatment approach. Based on the results of this trial, the company is conducting a Phase 2 study with an off-the-shelf microbiome therapy that is manufactured using a defined set of over 450 microbe species derived from healthy donors. The therapy is intended for graft-versus-host disease, a common complication of AML patients that are treated with a stem cell transplant in which the transplanted cells attack the patient’s body.

“At least half of the patients who have received a stem cell transplant will develop what we call acute graft-versus-host disease,” Mohammad Mohty, Professor of Hematology at Sorbonne University and scientific co-founder of MaaT Pharma, told Labiotech. “The standard first-line treatment is high doses of steroids, but after five to seven days you have a significant proportion of these patients who are not responding. This is a situation where you don’t have any approved drugs. Nothing has been shown to work over the last 30 or 40 years.”

Several other companies have started venturing into the microbiome field to search for new cancer treatments, such as Enterome in France or Microbiotica in the UK. However, most companies in the field are using or targeting a single bacterial species, whereas MaaT is going for more.

“It would be very naive to think that one bacteria or one species is going to do the job. We’re talking here about billions of members of this microbiome,” said Mohty. “We need to develop products which actually cover the whole spectrum of the microbiome in terms of diversity.”

Results from the ongoing clinical trial, proving whether the approach of MaaT Pharma can indeed help cancer patients, are expected within the coming months.

Steve’s Take:

Every time I read an article/paper on the gut microbiome I get this queasy feeling about having trillions of live bugs in me.

Here’s are a few head-snapping facts: The human microbiome is the genetic material of microbes such as bacteria, protozoa, viruses, and fungi which are present in or on a human body. The ratio of the number of the microbes to human cells is approximately 10:1.

Yes, you read that correctly.

The bacteria in the microbiome help to regulate our immune system, digest our food, protect against other bacteria, and produce vitamins which are necessary for body functioning. Due to these various benefits provided by human microbiome, there is an increase in the demand for global human microbiome Market.

Here are several reports that can be downloaded for free that are derived from the vast database used for the “Human Microbiome Market” study, segmented by Product Type and Disease Indication. Its subtitle is “Geography, Growth, Trends and Forecast (2018-2025).” I’ve included a very brief summary of some of the more important conclusions in each report

1) The market report by ProMarket Research, titled “Microbiome Drugs Market,” is an extensive research study which inspects the intensive structure of the present market around the globe. Designed by suitable systematic techniques such as SWOT (strengths, weaknesses opportunities, threats) analysis, the Microbiome Drugs market report shows a total assessment of the worldwide Microbiome Drugs market.

Sure enough, listed among the dominant players is Maat Pharma. Others include Pfizer, Second Genome, Seres Therapeutics, Enterome Bioscience, MicroBiome Therapeutics, Ritter Pharmaceuticals, Rebiotix, and OpenBiome.

2) Accorging to Mordor Intelligence, the global human microbiome market for 2017 is expected to account for nearly $273.40M, registering a cumulative average growth rate (CAGR) of about 22.6% during 2018-2025 (the forecast period). Moreover, the market is expected to reach $757.26M by 2025.

According to the Mordor report, “The rising incidence of lifestyle diseases at the global level is a strong driver for the microbiome market, as therapeutics may provide an alternative route to confront the significant healthcare challenges, such as obesity. The increasing occurrence of autoimmune disorders and antibiotic resistance are also important areas, where there is a need for fresh treatment approaches and, for which microbiome therapies may have a significant impact over the next few years. With advancements in precision medicine, personalized nutrition is also playing a crucial role.”

“Almost half of the total chronic disease deaths are attributable to cardiovascular diseases, obesity, and diabetes,” says Mordor. “Hence, this exorbitant increase in the lifestyle diseases across the globe is driving the market for the human microbiome, which is expected to increase in the future. Other factors, such as the growing geriatric population and increasing R&D investments, are driving the market growth.”

The report continues, “With the advancements in science and technology, scientists are getting increasingly excited about the potential and potency of fecal matter and the microbes in it. The FDA regulations on these procedures, however, keep them out of reach for most patients. Since 2013, FDA has banned doctors from doing fecal transplants on anything except Clostridium Difficile (C. diff). Stringent government regulations, pertaining to the approval of human microbiome-based therapies, are creating a major impediment for the market growth. The use of technology employing knowledge of the human microbiome is just getting started and not yet widely applied.”

Mordor concludes that, “In North America, the US is dominating the human microbiome market accounting for the highest share, due to the growing geriatric population and rising prevalence of diseases. Owing to improvements in the research infrastructure, Asia-Pacific is expected to record a substantial growth rate during the forecast period.”

3) Zion Market Research published a new report in September, 2018, titled, “Human Microbiome Market: Global Industry Perspective, Comprehensive Analysis and Forecast, 2017-2024.” The report was assembled:

• by Product (Probiotics, Prebiotics, Medical Foods, Supplements, and Others),
• by Application (Therapeutics and Diagnostics) and
• by Disease Type (Obesity, Diabetes, Autoimmune Disorder, Metabolic & Gastrointestinal Disorders, Cancer, and Other Diseases).

According to the report, the global human microbiome market was valued at approximately $721.63M in 2017 and is expected to generate revenue of around $1.365B by the end of 2024, growing at a CAGR of around 9.40% between 2018 and 2024.

All of which should give investors something to chew on as we move forward in this growing, potentially enormous market. So, don’t forget this little diamond in the rough, called Maat Pharma. I’ll continue to watch its (and others’) progress using gut-bug therapy and keep you posted.