The new drug is delivered in aerosol form
An “investigational new drug” (IND) application to treat chronic fatigue syndrome (ME/CFS )and long COVID has been filed with the FDA. We don’t see INDs – the documents that begin the drug trial process at the FDA – very often in ME/CFS. They indicate a company is confident enough in its treatment to start the road down to extensive clinical trials and ultimately, FDA drug approval.
The drug – Inspiritol – doesn’t seem, at first glance, to be a close fit for ME/CFS or long COVID. Originally developed to treat respiratory diseases like COPD but now being used to treat ME/CFS/long COVID it’s a nebulized, inhaled medication, composed of endogenously produced and naturally occurring, well-tolerated biochemicals that have anti-oxidant, anti-inflammatory, and broad-spectrum anti-viral and anti-bacterial properties.
One of the inventor’s LinkedIn account states that Dr. Salerno has successfully treated more than 70 patients with COPD, Asthma, Acute Phase COVID-19, and Post-COVID. International patents are pending. (I was unable to find Inspiritol in a U.S. Patent or Google Patent search but I may have made mistakes.)
The Creators
The formulation was developed by John Salerno, MD, and George Hoag Ph.D. Salerno seems to exist in the realm of pricey, media-savvy alternative health specialists. His website states he’s well known for his IV protocols, weight-loss treatments, and chelation therapy. Salerno, who appears to be an industry unto himself, has, according to his website, 7 affiliated centers in Tokyo, two in Brazil, and two in the United States. He’s co-founder of an anti-aging clinic in Tokyo, and chief medical officer of another in Brazil.
The Salerno Center in Manhattan focuses on alternative and complementary therapies
His books include “Fight Fat with Fat“, and the “Silver Cloud Diet”. The front page of his website notes that he’s been featured in all Suzanne Somers’s books. Tony Robbins’s recommendation sits on the front page of the website. He’s a different breed of doctor than most of us are probably accustomed to.
He sells his own brand of supplements. Shortly after the COVID-19 pandemic began in the U.S., Salerno introduced Immune Factor Plus, containing glycerol monolaurate – which, the website, citing a CDC laboratory study that showed it killed over 14 envelope viruses “of which COVID-19 is a part of”, called a “must-have nutrient”.
While Salerno’s practice has a kind of glitzy, Hollywoodish feel, it also focuses on many things that may be helpful in ME/CFS/FM such as low carbohydrate diets, the use of NAC/glutathione, thyroid and hormone testing, etc.
Salerno co-developed the Inspiritol preparation with an environmental engineer named George E. Hoag (PhD), who according to his LinkedIn bio, appears to be a jack-of-all trades kind of inventor. A former University of Connecticut professor, Hoag has published numerous research papers, has developed a cannabinoid drug, as well as environmental, oil and gas products, and has 11 U.S. patents with more than 29 currently pending.
While Salerno and Hoag exist in a different kind of world that most of us are not acquainted with, the researchers they’ve surrounded themselves provide some real ballast.
Enter The ME/CFS Connection: the Selin – Gil Duo
Salerno and Hoag tested out the effects of their preparation with Dr. Liisa Selin and Dr. Anna Gil at the UMass Chan Medical School. Dr. Selin MD, Ph.D., Professor of Pathology and a specialist in infectious diseases and immunology, and Dr. Gil Ph.D. just happen to be two quite exciting new entrants into the ME/CFS research field. It’s not clear how they got started, but they have said they have a personal connection to this field.
Selin is a well-published immunologist who recently produced an overview of viral immunology; i.e. she knows of what she speaks. Longtime ME/CFS researcher and practitioner Nancy Klimas gave her a big welcome to both the ME/CFS and long COVID fields:
“It’s exciting to see Liisa Selin’s work move to the next level. Her focus on immune exhaustion is right on target. Immune restoration as a treatment focus will be important to ME/CFS, and also to the post-COVID illness that is being called Long COVID or Post-Acute Sequelae of SARS CoV-2 Infection (PASC).“ Nancy Klimas, MD, Director, Institute for Neuro-Immune Medicine, Nova Southeastern University
A 2019 Solve ME/CFS Ramsay Award, “Altered T cells in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)”, started Selin and Gil off.
The Gist
- Inspiritol, Inc. announced that it’s in the process of getting an “investigational new drug” (IND) application approved by the FDA. The IND is the first step in the process of doing FDA-approved clinical trials and ultimately FDA approval.
- The aerosolized (nebulized) drug, which has been in development since at least 2019, was originally developed to treat lung disorders but is now being used to treat long COVID and ME/CFS as well. It was created by John Salerno MD and George Hoag.
- Salerno is a New York complementary and alternative health MD with a decidedly upscale practice in Manhattan and with affiliations to anti-aging clinics outside of the country. Hoag is an environmental engineer who has many patents pending.
- Two ME/CFS researchers (Drs’ Selin and Gil) who recently received a $2.5 million NIH grant, have been assessing the drugs impact on the immune system and symptoms, and have reported favorably on its results. Dr. Selin, who has been taking the drug, urged the FDA to quickly approve the drug for clinical trials in ME/CFS and long COVID
- Hoag reported that Inspiritol, Inc. is currently preparing for laboratory and clinical testing.
- The Inspiritol trial is surely just one of many that we’ll be seeing in long COVID. Health Rising has already reported on fecal transplant, oxaloacetate, the Bruce Patterson effort, and now Inspiritol. the boom in long COVID treatment trials is likely just beginning
“In my long career of studying human T cell responses during viral infections I have never previously observed an increase in this cell type (CD4+ CD8+)”.
Nothing fits this mysterious disease so well – and nothing is more encouraging to me than a strange result that makes researchers shake their heads.
Those T-cells Selin glommed onto weren’t just laying around playing hooky: they were charged up and pumping out cytokines. Identifying what turned on these enormously powerful T-cells could tell us much. The NIH was interested enough in her unusual findings to grant Selin a rare, major, RO1 grant for ME/CFS in March of this year. Health Rising will hopefully have more on the $2.5 million grant later, but suffice it to say that Salerno and Hoag did well when they picked Selin and Gil to check out the effects of their new treatment approach.
After running their biomarker tests on two patients with long-COVID and one with ME/CFS who’d been on Inspiritol from 2-5 months, Selin and Gil found “dramatic improvement of these patients’ symptoms” and with their immune profiles modulating towards normal following the use of Inspiritol for 2-5 months.
In the FDA application, Selin noted the “ever-increasing number” of patients being safely treated with Inspiritol. As she urged the FDA to support a quick move into long-COVID and ME/CFS clinical trials, she suggested that she, herself, might be the personal connection to ME/CFS she’d referred to before.
“Based on our results and those reported by Dr. Salerno and Inspiritol… I think it is very important that we be able to run controlled clinical trials with FDA approval using this treatment in both ME/CFS and Long-COVID patients. It is urgent that we move quickly into clinical trials in Long-COVID patients with this safe medication, which I have taken myself now for more than 5 months.”
The evidence, so far, is anecdotal, but it’s apparently encouraging enough for Inspiritol, Inc to start the IND process to begin clinical trials for long-COVID, and ME/CFS (Myalgic encephalomyelitis/chronic fatigue syndrome). Inspiritol, Inc. reported that in mid-2021, the FDA’s laid out its next steps which included “combinatorial nonclinical inhalation animal tests and a Phase I clinical trial.” Hoag reported that “Inspiritol is currently preparing for nonclinical and clinical testing”.
Long COVID Clinical Trial Boom Beginning?
Time, of course, will tell how this new drug works out but it appears that the anticipated long-COVID boom of clinical trials has begun. The Clinicaltrials.gov already contains over 100 citations and Health Rising has reported on fecal transplant, oxaloacetate, the Bruce Patterson effort, and now Inspiritol long-COVID clinical trials. They are surely just the tip of an iceberg for a disease that will surely launch dozens if not hundreds of clinical trials, any one of which could also impact ME/CFS, FM, and other diseases.Inter
Interested in what’s going on with long COVID research? Check out our second long COVID research review.
Sounds like another in a long line of moneymaking scams that will be the subject of a lot of hype and then die down and essentially disappear without much fanfare when it doesn’t pan out in reality. All we can do is reserve judgment until actual ME/CFS patients – not study developer accomplices who probably don’t even have real MC/CFS – take it and have success with it.
I was not excited by Dr. Salerno’s bio either. For all I know he’s a fine doctor but he’s definitely out of my orbit. Those two researchers though who have won both a Ramsay Award and a rare NIH grant – and one of whom may have ME/CFS… I would hang my hat on them. I’d also bet that a pretty well-accomplished researcher who’s dived into this field headfirst probably has a pretty good idea whether she had ME/CFS or not.
Here is a recent interview with Dr. Selin. Timestamps are in the comments, including discussion of Inspiritol. Dr. Selin talks about her own experience with ME/CFS and how Inspiritol rescued her from a vaccine-induced crash. She claims that it has gradually ameliorated some of her long-standing ME/CFS symptoms as well.
https://www.youtube.com/watch?v=aV2Jr2NsrFw&t=2725s
Hi – I don’t mind scientists being savvy business men. At least they have done full cycle product introductions and are moving forward with two big grants. Not like many researchers we never heard where their research ended up in. or those famous Doctors like Montoya who was a fake, but used millions and wasted them. Once Stanford was #1 moving forward with actually healing patients (they made us believe), but it was nothing but publicity. SO hopefully this will actually move forward.
not directly on this topic but also treatment for ME/cfs.
Cort do you maybe know when finally the oh so long waited treatment trials of combo theraphy from nancy klimas will start? it takes litterally ages…
thanks!
Good question, it has been aaaaaages….
Well if Lisa Selin thinks it’s a promising thing, I’m willing to be hopeful. It would be wonderful if there was a large open trial that included ME/CFS patients who have been sick for years, decades and lifetimes, and not just the shiny new “Long” Covid folks.
Cort, thank you for this report. I think that the push for long Covid treatment may help move the IND for this new drug along rapidly.
A nebulized, inhaled medication, composed of endogenously produced and naturally occurring, well-tolerated biochemicals that have anti-oxidant, anti-inflammatory, and broad-spectrum anti-viral and anti-bacterial properties sounds like a good fit for most of the problems in both illnesses.
I know that everyone like me who has had ME/CFS for years and years feels like long Covid cases are getting attention we never did. Who cares? I say whatever it takes.
Agreed Mary – whatever it takes! 🙂
AMEN
Cort,
My apologies if this is a dumb question, but why is the object of this treatment aimed at enhancing the immune system, when lots of us are on methotrexate to quiet it down ?
The immune system is tricky. Some researchers say part of it is upregulated in ME/CFS while another part is downregulated. If that’s true the trick would be to pump up one part and not the other. Maybe you’ve got half the game going (???)
Don’t researchers thinks our immune systems are revved up earlier in the illness, and suppressed later?
I had lots of allergies earlier in my CFS, which started going away after about 8 years.
I don’t know for sure, but suspect in my own case my immune system was really hyped up EARLIER in the illness.
Wish they would say what is in it.
Chris, I entirely agree.
Plus, what does “endogenously produced” and “naturally occurring” mean, anyway? Endogenously produced within each patient? A super individually tailored nasal inhalation treatment?
What other drug on the market is “endogenously produced” as an example?
Is the patient the Petrie dish in which the drug is cultured? If so, sounds like one super pricey treatment.
I tried to find the patent application in order to find out what was in it but couldn’t find it. If anyone can find it that would be great.
Hi Cort and all,
Here is a web link to what looks like the patent application.
https://patents.justia.com/patent/20220000966
“Composition and Method for Treating the Lungs”
Inventors: George Edward Hoag and John Salerno
It was filed on October 23, 2019, but was not published until January 6, 2022.
Thank you Cort and all for the intriguing information, and best regards.
Hi again Cort and everyone,
Here is a web link to a pdf file of a companion international patent application. Being a pdf image file, it has figures and tables. (The first link above was all text.)
https://patentimages.storage.googleapis.com/41/58/ef/815a80637ec687/WO2020086759A2.pdf
Hi once more Cort and everyone,
The patent applications include many potential ingredients and formulas. Perhaps the formula(s) of interest for ME/CFS and Long-Covid is (are) the same or similar to one or more of the formulas described in Tables 1 through 18 (starting at page 58) of the international patent application (?).
These tables might be easier reading than the “text only” US patent application web link. I didn’t find a web link for the US application that included formatted tables and figures. Without reading the applications in detail, I’m guessing that the information in them is the same. (From US application) “The present application is a national phase entry under 35 USC § 371 of international application number PCT/US2019/057722, filed Oct. 23, 2019, ….”
I’m guessing that Inspiritol, Inc. is keeping the formula(s) for ME/CFS and Long-Covid as trade secrets; and that Doctors Selin and Gil are honoring the trade secrets, per a non-disclosure agreement with Inspiritol, Inc.
Best regards to all.
I read some of Dr Salerno’s blog and my guess is that it is nebulized glutathione and NAC – and possibly some other natural product ingredients (magnesium?). I doubt there are any novel substances in it.
I think it could work; I hope they get a trial going.
Does anyone feel some relief with Guaifenesin?
I had an astonishing result with Guaifenesin 10 years ago. I took the max dose and felt worse (as was predicted) for 2-3 months, and then fairly suddenly felt remarkably better.
Sadly I feel like my disease has still progressed with less energy & more infectious flare-ups, but I think it helped me back then, until I got a serious tick-borne infection.
You can find info on a protocol online. Good luck.
Hi Karen – I have found great benefit, much pain relief from guaifenesin. Excruciating neck and back, fibromyalgia pain improved within 1-2 years of daily guaifenesin, taken per protocol which involves not using salicylates which block guaifenesin. Although it didn’t improve ME, to have half the symptoms (pain and some immune related ones) gone improves QOL greatly.
TY
Does anyone know how to get in touch with the people that can get us into the trial, because this is the first one that I have had any kind of slight enthusiasm for to deal with my 25 year ME/CFS?
I don’t think they are up to the trial yet. It looks like animal and lab studies first (?) then a first clinical trial. Health Rising will promote it when it happens.
Let’s assume this treatment ends up being effective and approved by the FDA, all clinical trials show significant improvement, etc. How long before I can get the freaking treatment? Like 5 years? The time involved to approve this stuff makes me so infuriated. Someone out there has the cure. I’m 52 and I have had this miserable disease for 20 years. Can I have some decent years in my already-old-age without waiting until I’m in my mid 60s? Life is such an effin waste!
It always takes longer than we would hope unfortunately.
Good to know more of the backstory and context with this post.
The one thing that had me a bit puzzled from the press release is that it shows a “rapid increase of oxygen in the blood”, which seems to possibly run counter to Dr. Systrom’s iCPET results showing that at least one subset of ME/CFS patients have high blood oxygen levels presumed due to poor peripheral oxygen extraction.
I wonder if there will be subtypes of ME/CFS and this may prove effective for just that one.
Or of course there may be something I’m missing….
Good catch Vijer! It would seem not to help with oxygen extraction in that group of patients. Hopefully we will find out about the formulation at some point.
I do not get why no one is getting the Immune Globulin shots as I did years ago. I became sick 1987. Went to an Infectious Disease Dr -Dr Richard DeBoise. He was treating Aides patients. I had Epstein Barr and Cytomegalavirus. From 1-2 weeks after I started getting the Immune Globulin shots I started to improve. Then Bayer sold out to a small company in NC and then out of the US. The copy of the meds never worked fro me. It was Generic. Why not use this if it is still available for the issues now? It is frustrating. I even felt some improvement from the Moderna vaccine??? I did not have Covid. It seems to me we and the researchers on my MALADY just keep jumping around and never finish.
I felt better each of three Moderna vaccines. Over 65 I got the high dose booster. After each injection I woke up refreshed. Ready to go, all day for just a couple days. Effects went down pretty quickly after the first 3/3 day
I was very skeptical when I started reading this article, but have come around a bit to the *possibility*.
But let’s wait and see.
I can’t find anything on the internet that says more than Cort’s article.
I’m curious as to whether in fact this drug has ever been used for COPD patients except the few in Dr. Salerno’s sample.
Does it exist except in this experimental stage?
There hasn’t been much on it so far as I can tell until the press release. Salerno apparently had a blog or two on it on his website but that blog/blogs have been removed for some reason.
Cort, thank you for yet another exceptional and very intriguing article, as always!
Meanwhile:
Am I missing something? This new drug has been used by a number of Dr. Salerno’s patients but has not been tested and vetted? And nobody is questioning that?
Is this use of an untested drug even allowed? … or merely sketchy?
So … perhaps that is why some of the blog posts from Dr. Salerno’s site were removed.
On the other hand, like many of us I’m so sick & tired of being sick & tired — I’m tempted to contact these doctors; I kind of want to be first on the list when they’re rounding up human test subjects. If this makes sense to you then you are ahead of me.
I don’t know how this works. I wonder if it’s composed of all-natural ingredients – and that makes the difference? And he’s going to the FDA because he wants the cachet of FDA approval (????)
Here you go Cort.
https://web.archive.org/web/20210121181611/https://salernocenter.com/2020/09/inspiritol-and-covid-19-testing/
Cort Thank you for all your info and continued research. I am wondering who is available anywhere near Atlanta for testing . We do have Emory here. Thank you again.
Ok, here’s a p.s.: It looks like the new treatment is likely going to be a proprietary combination of substances — maybe really novel maybe not so much — substances that are already established but established in other ways, forms, or methods. It seems they’ve had compounding pharmacists making it on a prescription basis, yet not necessarily made from prescription-type ingredients. Perhaps Inspiritol will be classified as a drug, or else as a medical treatment, a non-drug/natural treatment, or otherwise. We’ll see!
The substances they have for this treatment apparently are already around, and apparently already naturally occurring inside most of us… so already GRAS, generally recognized as safe. For instance, hydrogen, or the anti-oxidant co-Q-10, or amino acids are already inside of us.
There’s no actual statement saying that Inspiritol (product name) is used in a U.S. patent application — but is used in a trademark application. They do say that Inspiritol Inc. has submitted patent applications although not necessarily for this one product applied for as a specifically U.S. patent (as opposed to an international patent) and not using that company name, or the brand name in the application of course.
This brings to mind another company, Metagenics, and Metagenics’ product UltraInflammX. UltraInflammX is officially only available through one’s healthcare provider, and its label warns something like: “This is only for use under supervision of physician or healthcare professional.”
Whether Inspiritol gets classified as (I’ll wager) available only from a healthcare provider, as opposed Rx or OTC, might be a matter of FDA’s ruling, or somebody’s lobbying, or marketing. I think that depends on how things go with the FDA, which might be lobby-able or not lobby-able. I live on the edge of Washington, DC; my head is swimming from countless stories from food/drug/medical device lobbyists and marketers. Heck, this stuff _might_ not even be viewed by our government as novel enough and patentable!
As for the gist of this, let’s hope they don’t end up creating a pricey pseudo-cartel, hope that they’re not able to hype up a mushroom cloud of consumer demand, hope that we get affordable access, and that the new compound will do us a lot of good. All I ask is to see the future, is that so much?!?
Pricy pseudo-cartel–well said, and I agree. I’ve seen family members consumed by the doctor-sold supplements til their cash runs out. It’s too bad that we ME patients have to navigate that as part of our search for adequate care.
Another Anne: sustainable, real-world treatment costs- as opposed to leveraged & inflated prices for Rx’s/OTCs/nutritionals, would be a huge improvement. I’d like to be a lobbyist for that issue if I had less fatigue!
“pricey pseudo-cartel” yep EXACTLY what is already happening @ $20 a day for one vial split 3/daily. $7300 a year and recommend be on full dose for a good 2 yrs. So, $14,600 for nebulized vitamins. Can’t even IMAGINE what the mark up might be on these vitamins. I know nothing is cheap, but really? What about $10/day, that would be more doable? Probably still be able to purchase his yachts, gold chains and fancy cars. Truth is, most of us would pay it, if we knew it would help! Seems to me that someone in the know might be able to locate their FDA application which might include ingredients?
I just hope it doesn’t end up being another PACE like trial that ends up doing more harm than good. Never trust a practitioner of any type that sells supplements, especially their OWN brand. Can you say ‘conflict of interest’?!
Still scratching my head about the endogenously produced part. And, the term natural does not necessarily equate safe and/or effective. I remain skeptical. I don’t know if it’s the same new drug going to larger trials that I heard about thru the Bateman Horne Center, but they weren’t as optimistic as the drug makers were.
Wendy, Good points. Some of us have way too much (endogenous) cortisol. It’s endogenous but I’m told it’s probably a cause of a lot of my chronic pain.
Yes! Not everything endogenous, which in this context basically means something that our bodies produce, is good. There can be both too little or too much!
I went to Salerno last week and started on Inspiritol today. I’ll report back
Good luck BarbaraC – looking forward to hearing how it goes. 🙂
BarbataC Any updates on your treatments? I would think after a year-and-a-half you would know whether Inspiritol helps or not?
Barbara- any updates on Inspiritol yet?
Well. I can say this about ME/CFIDS. Disappointed to hear they think there’s no inflammation in the brain from this. I’ve had Spect Scans ( Scans the brain different than an MRI).. All of mine showed swollen parts in the front Lobes.. Low blood flow– when I’m sick and have bad brain fog..I even told them where they would find it.. Only because my brain had a pressure like headache in that area. I have studied all the symptoms and had many diagnosed viral and bacterial infections. I’ve had this all my life I believe.. Bad onset at 28 years old. Anyway, Dr. Amen Phychiatrist,
has a new book called “The End of mental illness as we know it” / It really hits hard on the mental health system diagnosing all kinds of ” label’ mental illness. Of course, many of us have been labeled at some point. He does Spect Scans of every patients brain and from there he discovers all brain injury..Treats the brain injury with medicines that get the patient well.. There are 3 pages on herpes six, Cmv and Epstein Barr virus’s.. What an eye opener!! keep the faith . I miss Dr. Jose C from Stanford University. He was right on with Herpes Six B research..Nila
Time will tell about inflammation in the brain – we need much bigger studies.
Cort, don’t know if you saw it but a paper just came out on this drug and other things by Selin, Klimas, Horing and others.
Hi, just curious as to the status of this very hopeful sounding drug. Still years out? Thanks!