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Nestle Invests $65 Million In A Microbiome Fad

Or, take your pick: maybe they stepped up to back up the FDA in putting the kibosh on fecal transplants. Or, maybe the FDA decided to let 100,000 or so more people die from C. diff in the name of drug company profits, which would absolutely be the first time anything like that happened.

Nestle backs microbiome firm Seres with $65 million

Nestle Health Science, a subsidiary of the Swiss food giant, has invested $65 million into the USA’s Seres Health.

Seres is developing a novel class of biological drugs that are designed to treat diseases by restoring the function of a dysbiotic microbiome. Its portfolio currently focuses infectious, metabolic and inflammatory diseases.

The money from Nestle Health Science will help the progress of Seres’ lead product candidate, SER-109, for preventing the recurrence of Clostridium difficile infection, into Phase III trials.

And: Seres Health Presents Final Data for Study of SER-109 in Recurrent Clostridium difficile Infection at ICAAC 2014 Conference.

Cambridge, Massachusetts — September 10, 2014 — CAMBRIDGE, Mass., Sept. 8, 2014 /PRNewswire/ — Seres Health, a clinical-stage therapeutics company developing novel treatments for diseases related to the human microbiome, today announced final data for its single-arm, open-label clinical trial of SER-109, its first-in-field, oral microbiome therapeutic. SER-109, a mixture of bacterial spores, is designed for the treatment of recurrent Clostridium difficile Infection (CDI). The data presented at the 2014 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) show that in patients with recurrent CDI, SER-109 resulted in clinical cures, with 29 of the trial’s 30 patients (97 percent) reaching the 8-week endpoint free of infection.

Uh, I’m not sure, but I suspect that in the pharmaceutical world there’s an official expression for a “drug” with a proven 97% cure rate. “Holly Fucking Shit!” comes to mind, but it’s probably a trade secret (no patent required).

Oh, one more point from that article, and it’s difficult to emphasize only any one part.

Analysis of the microbiome using next-generation sequencing technology demonstrated that a single oral dose of SER-109 was capable of generating long-term changes in the microbiome, including the restoration of microbial diversity in the gastrointestinal (GI) tract of patients. Evidence for this was the engraftment of spore forming commensal bacteria from SER-109 in the patient’s gut microbiota over the 8-week period. Unexpectedly, it was also determined that SER-109 catalyzed the outgrowth of other healthy non-spore forming organisms in the GI tract. This included critical genera that were missing in patients due to long term exposure to antibiotics.

Those who’ve been following our ridiculous foray into resistant starch prebiotics and SPORE FORMING probiotics over 2 years, 130 posts, and 10,000 comments know the ridicule endured—particularly when it came to “peddling dirt.” Well, Nestle just invested $65 million into edible dirt.

And take particular note of this: “Unexpectedly, it was also determined that SER-109 catalyzed the outgrowth of other healthy non-spore forming organisms in the GI tract. This included critical genera that were missing in patients due to long term exposure to antibiotics.”

Now, recall that in addition to the ignorant scoffers, there were the far worse yogurt and kefir-making hand wavers and wringers who thought dairy is the only way to get a probiotic and not the earth itself, because it killz U or something. But in actuality, looks like those spore aliens might help those ugly lacto stepchildren stay put—or fit into a glass slipper.

Finally, one of my regular interlocutors took the time to look up Seres’ patent application for SER-109: Synergistic bacterial compositions and methods of production and use thereof. Among lots of interesting stuff:

Fecal transplantation has been shown to be an effective treatment for patients suffering from severe or refractory GI infections by repopulating the gut with a diverse array of microbes that control key pathogens by creating an ecological environment inimical to their proliferation and survival. Such approaches have demonstrated significant potential to decrease host susceptibility to infection. Fecal transplantation, however, is considered to be a procedure of last resort because it has the potential to transmit infectious or allergenic agents between hosts, involves the transmission of potentially hundreds of unknown strains from donor to patient, and is difficult to perform on a mass scale. Additionally, fecal transplantation is inherently nonstandardized and different desired and/or undesired material may be transmitted in any given donation. Fecal transplantation is not approved by the FDA and is unlikely to gain approval since the product cannot be standardized and characterized according to regulatory requirements for identity, potency, purity and safety. Thus, there is a need for defined compositions that can be used to decrease susceptibility to infection and/or that facilitate restoration of a healthy gut microbiota.

Thus practitioners have a need for a much safer and reproducible treatment for disorders currently treated on an experimental (non-FDA approved) basis using fecal transplantation. In order to prepare a therapeutic with commercial potential, we have designed bacterial compositions of isolated bacterial strains with a plurality of beneficial properties based on our understanding of those bacterial strains and our analysis of the properties that would enhance the utility and commercialization of a bacterial composition.

The very short version of that is that the FDA is such a dinosaur, that it’s impossible to develop a lot of new cures or therapies, because it’s locked in an old institutional paradigm where anything worthwhile ought to be able to be deconstructed—to a chemical equation in the case of drugs.

As we’re increasingly coming to understand, the complexity of earth’s biome defies such scientism.

Richard Nikoley

I'm Richard Nikoley. Free The Animal began in 2003 and as of 2021, contains 5,000 posts. I blog what I wish...from health, diet, and food to travel and lifestyle; to politics, social antagonism, expat-living location and time independent—while you sleep—income. I celebrate the audacity and hubris to live by your own exclusive authority and take your own chances. Read More

16 Comments

  1. gabkad on January 9, 2015 at 18:23

    So the FDA ‘sheltered’ little start ups like Seres until they could sell out to the big boys? And make their shareholders happy?
    http://sereshealth.com/

    …..pity about those patients.

    • newbie on January 10, 2015 at 04:42

      OK, at the risk of severely dating myself, let’s put some perspective on this.
      When I was in med school, in the late 70s, a Hep B immunization was developed, and they gave it to all of the med students. The kicker, it was made from the blood of gay men, because they had lots of Hep B antibody. Then we found out that they also had HIV( in the early 80s), and a recombinant vaccine was produced, not requiring the use of human biologic fluids. Who would opt for the original vaccine ?- nobody today would – there is safer technology. I think the same applies to this infancy of fecal transplant – how do you you know what it accompanying the good bugs?? I occasionally agree with government policy, and this is one of those occasions.



    • Richard Nikoley on January 10, 2015 at 08:51

      I understand where you’re coming from, Newbie.

      However, do keep in mind that this and many other drug disasters were caused by the very people you claim need to be the guardians against that happening.

      It’s kinda like saying “we need the Department of Labor because people are sometimes unemployed.”

      IOW, from my libertarian perspective, this is the most common form of fallacy I’ve dealt with going way way back.

      That said, I have no qualms at all about this sort of R&D and at minimum, there’s definitely a pure science aspect that leads to more knowledge, etc. I just don’t think GovCo as father and gatekeeper serves us well; what benefits offered are always offset by downsides and often enough, overwhelmed by them.

      Lots of people die from c. diff (15,000 in the US alone each year). If I had it and it was hospital bad, that new drug wasn’t available (happy to try it if it were), and a fecal transplant wasn’t available from a proven professional source (sanctioned by GovCo or not), then I’d certainly pursue a DIY. I pretty much assume that almost anyone in that situation would be perfectly willing to lift a high middle finger to the FDA and all other hand wringers whose lives are NOT on the line but are yet perfectly delighted to gamble with the lives of others. America is a nation of chicken hawks in ALL RESPECTS, now, don’t forget.

      Fortunately, there’s now the Internet and unless completely superseded by something less costly and more effective, DIY fecal transplants are here to stay and there’s nothing any State can do about it.



    • gabkad on January 10, 2015 at 09:50

      newbie, the other thing is how much will it cost a patient to take this probiotic? If Nestle has invested $65 million dollars, clearly profiting from this investment is number one. They must be anticipating more than C. diff applications. Maybe this is the next Lipitor. Or the next fortification product in breakfast cereal, yogurt, infant formula or whatever.



    • newbie on January 10, 2015 at 14:55

      Actually Richard, I agree with every point you’ve made. And yes, I would DIY too and let the bugs duke it out, survival of the fittest!



    • newbie on January 10, 2015 at 14:59

      That’s the thing gabkad, they will want to make their investment back plus some – as Lipitor has many times over. I am sure they are envisioning a wider range of applications – likely many of the leaky gut disease, arguing that the defective biofilm is at issue in these cases. And you can bet they will charge!



  2. John on January 10, 2015 at 04:18

    I always buy grade “b.” I imagine the darker, higher “impurity” (less fancy) syrup is higher in these beneficial compounds. I simply prefer the higher mapliness.

    • John on January 10, 2015 at 04:20

      Weird I hit reply on the maple post. That’s what I get for commenting from my phone.



  3. Robert on January 10, 2015 at 10:42

    This reminded me of something I came across recently….a traditional Korean rice wine called “Ttongsul” which is basically fermented human faeces with reportedly wide ranging health benefits.

    http://www.dailymail.co.uk/health/article-2398130/Ttongsul-bizarre-traditional-Korean-rice-wine-uses-human-POO-heal.html

    I’m not sure how much of the good bugs remain after fermentation, but it’s interesting nonetheless. Either way, with possible probiotic properties and an alcohol content of 9%, this traditional drink would certainly be a conversation starter at the next cocktail party , right?

  4. Steven on January 10, 2015 at 16:48

    Nothing new here to see. On to the next adventure in making me healthier. Oh wait… you mean people out there don’t believe how important bacteria are?

    FDA=Fascist Dated Assholes.

    Well done Richard. I would say lay off of the VLC crowd as they are not worth the effort but I guess keeping others from falling in to that trap is critical.

  5. Hegemon on January 10, 2015 at 20:33

    There has been speculation that a synthetic bacterial pill treatment for C. diff might pave the way for a similar pill that could cure celiac disease. As one who deals with it, I would love a magic pill that would cure it. But I’m not holding my breath for this from the drug companies. More likely they are cooking up “disease management”, i.e., “take this pill for the rest of your life.” Or in other words, $$$. Gotta love it when human wellbeing and capitalism mix.

  6. marie on January 11, 2015 at 09:48

    Mon cher, Sunday Church for Animals comes to mind today : Je suis Charlie.

  7. Gassman on January 11, 2015 at 12:23

    But what about all those other drugs that are approved and turn out to do more damage than good? Phen-fen anyone? I’m just so fed up with those lawyer advertisements for FDA approved medical treatments. I know when a Dr. perscribes a drug for me that it may be harmful. Thats why I trad Free The Animal and try to stay well.

  8. James Lyons-Weiler, PhD on April 8, 2015 at 09:47

    The science behind the efficacy of FMT is good. There are a variety of options for delivery, and the side effects and risks are known, but minimal. Infection of other agents with FMT is a possibility; I believe the docs can be choosy as to the donor (spouse, sibling, etc) at the request of any concerned patient. The pill is designed to deliver a microbiome replenishing dose that can survive digestion. I think FMT and derived treatments are great given that previous standards of treatment (e.g., vancomycin taper) not work nearly as well. I don’t understand the comments about letting people die from C. diff given that the FDA stopped requiring an IND in 2013? Am I missing something? Disclosure: I have no conflicts other than my role as author on a forthcoming book on successes in translational research.

  9. Tom shamp on May 30, 2016 at 18:48

    I work for seres therapeutics. Keep in mind, this treatment is a one time dose. Take it one time and youre done. Which is excellent in terms of drugs. Alot of other drugs on the market aim to make you keep taking them month after month.

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