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 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.
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.