FAIRFIELD, Conn., Oct. 25, 2021 /PRNewswire/ -- Inspiritol, Inc., a virtual pharmaceutical start-up filed a response with the FDA as part of their Investigational New Drug Application process for Inspiritol, a novel treatment for COVID-19, Long-COVID, and ME/CFS (Myalgic encephalomyelitis/chronic fatigue). Inspiritol is a nebulized inhaled multi-mechanism medication designed to treat the major symptoms of respiratory distress with anti-oxidant, anti-inflammatory, and broad spectrum anti-viral and anti-bacterial properties. Inspiritol is comprised of both endogenously produced and naturally occurring, well tolerated biochemicals co-developed by Dr. John P. Salerno, MD with a practice in New York City and George E. Hoag, Ph.D. Inspiritol, Inc. has several U.S. and foreign patent applications pending.
Since 2018, Dr. Salerno treated patients diagnosed with COPD, Asthma, COVID-19, Long-COVID, and ME/CFS with Inspiritol. Inspiritol Inc. is seeking approval from the FDA to conduct human clinical trials on patients with COVID-19, Long-COVID and ME/CFS. Dr. Salerno stated, "A hallmark of Inspiritol treated patients is a rapid increase of oxygen in their blood and decreases in fatigue and difficulty thinking, commonly referred to as 'brain fog'."
Dr. Liisa Selin, MD, Ph.D., Professor of Pathology and a specialist in infectious diseases and immunology with Anna Gil, Ph.D., both at UMass Chan Medical School have developed new methods to study biomarkers of chronic inflammatory diseases. They discovered similarities in immune system responses of Long-COVID and ME/CFS patients, including CD8 T cell exhaustion, increased frequency of CD4+CD8+ T cells, and difficulty controlling persistent viral pathogens. Dr. Selin said, "Our research findings could point to potential biomarkers, treatments and ways of tracking responses to therapies for Long-COVID and ME/CFS, methods that are immediately needed. Our research indicates that individuals with Long-COVID and ME/CFS have biological abnormalities, including; oxidative stress imbalances, systemic inflammation and neuroinflammation." Working with Dr. Salerno's patients, Dr. Selin and Dr. Gil ran these same biomarker tests on two with Long-COVID and one with ME/CFS and reported, "We obtained dramatic improvement of these patients' symptoms associated with changes in their biomarkers without evidence of any significant side effects, including routine blood work, following continuous Inspiritol therapy from 2 to more than 5 months."
With the same biomarker analyses used to characterize these patients' immunological states, they reported, "As the patient improves on the Inspiritol treatment, we found it is also modulating their immune response towards a more normal profile." In fact Dr. Selin wrote to the FDA, reporting on these results, and concluded, "Based on our results and those reported by Dr. Salerno and Inspiritol in their FDA application, no adverse side effects have been reported in an ever increasing number of treated patients. 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 opportunity to intervene on Long-COVID patients is very narrow before they become more chronic, like more severe ME/CFS patients who will, I think, be more challenging to treat and reverse the long-term immune and metabolic dysfunction that they have endured."
Inspiritol, Inc. today also announced the appointment of Dr. Ray Welsh as Senior Science Advisor. "We are delighted to appoint Dr. Welsh, an internationally recognized scientist who has made many important discoveries in the field of immunology and virology," Merturi said. Dr. Welsh is Emeritus Professor and former Chair of the Immunology and Virology Program at UMass Chan Medical School. He has served as Editor of the Journal of Virology and Associate Editor of the Journal of Immunology. Dr. Welsh has authored 280 papers and co-authored a book titled "Viruses and the Lung: Infections and Non-Infectious Viral-Linked Lung Disorders".
Contact: John Merturi