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 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.
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.
- 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.