First Biotech to complete a Phase III for Long Hauler COVID-19 symptoms
First Biotech to complete a Phase III for Long Hauler COVID-19 symptoms
By Robert Millar | February 9, 2022 | Blog
EmphyCorp www.EmphyCorp.com is the first Biotech to complete a Phase III for COVID Long Hauler symptoms.
Our Patented Rx N115 Nasal Spray technology immediately clears the nose of congestion and increases Nasal Nitric Oxide to kill all viruses, bacteria, and fungi. It also improves breathing, increases Sa02 and lung functions. N115 reduces hypoxemia (low SaO2), fatigue, coughing/sneezing, trouble breathing, body aches, headaches in patients with Long Hauler COVID symptoms and improved all lung functions in patients with Pulmonary Fibrosis.
Dr. Martin, "Being a Non-Steroidal spray that increases nasal nitric oxide is key, because nasal steroids and other OTC nasal treatments shut down the synthesis of nasal nitric oxide, which then leads to decreased lung function and a 12%-34% increase in infections, depending upon age or underlying disease."
“Given our success in treating Pulmonary Fibrosis patients and the other respiratory diseases, our research focused on treating the symptoms in COVID-19 infected patients and in long hauler COVID patients, including hypoxemia (low SaO2), fatigue, coughing/sneezing, trouble breathing, body aches, headaches, and preventing lung fibrosis”.
There are approximately twelve million Americans with COVID-19 Long Hauler Symptoms, including athletes, which are at serious risk of developing Pulmonary Fibrosis (7-10% JAMA). Conversely, patients with Pulmonary Fibrosis have an increased risk and susceptibility to COVID-19 infection, which can reach a mortality rate of 50%. N115 is poised to help COVID-19 Long Haulers recover from this disease by reducing their symptoms including hypoxemia low (SaO2), fatigue, coughing/sneezing, trouble breathing, body aches, headaches, and lung damage.
EmphyCorp Patented Rx N115 Nasal Spray with no know side effects has successfully completed Phase III Clinical Trials for Pulmonary Fibrosis, COVID-19, and COVID Long Haulers.
To download the Press Release with Phase III Results, please go to the EmphyCorp Website PR-Newswire-EmphyCorp-Inc.-N115-Nasal-Spray-Completed-Phase-III-Clinical-Trial-for-COVID-19-Long-Haulers-and-Pulmonary-Fibrosis-100521.pdf (netdna-ssl.com)
Study evaluates treatment of ‘long COVID’ patients
Your source for what's happening at Missouri State University
Study evaluates treatment of ‘long COVID’ patients
N115 shows promise on debilitating symptoms.
November 2, 2021 by Strategic Communication
Fatigue, headaches, coughing and difficulty breathing: These symptoms affect daily life for people living with long COVID.
This is a condition marked by persistent symptoms long after a person initially recovered from COVID-19.
While so much is still unknown about how COVID-19 will continue to affect the health of those who survived, Dr. Christopher Lupfer, assistant professor of biology at Missouri State University, participated in a promising collaborative clinical trial.
He and the other researchers studied how N115, a natural product that consists of sodium pyruvate, reduces the symptoms of long COVID.
“Pyruvate is present in every cell of the body and is important for energy,” Lupfer said.
He also lists its antioxidant qualities, as well as its ability to increase nitric oxide, which improves lung function and fights infection.
The U.S. Food and Drug Administration is currently evaluating N115.
After participating in this study, Lupfer said, “N115 will hopefully be approved and marketed soon.”
Improved breathing, fewer headaches
The study included 22 patients with long COVID.
The research team monitored each patient for one week to establish a baseline of symptoms for each individual.
Then, they gave the patients N115 for one week. Their vital signs and symptoms were recorded and compared to the baselines.
“All 22 patients saw improvement in vital signs or disease symptoms compared to the week with no treatment,” Lupfer said.
This included improved breathing, less coughing and fewer headaches.
“Their blood oxygen levels also improved, demonstrating that patients were breathing better,” he added.
Coming together for greater results
The study was done in collaboration with:
- Emphycorp Inc.
- Dynamic DNA Labs.
- Trinity Healthcare.
- Family First Medical Research Clinic.
“We would like to thank Emphycorp for working with us to test this promising treatment, and our collaborators Dynamic DNA Labs, Trinity Healthcare and Family First Medical Research Clinic for their valuable support,” Lupfer said. “We especially thank the long COVID patients who participated in the clinical trial.”
The study is now published on ClinicalTrials.gov and the European Journal of Respiratory Medicine.
European Journal of Respiratory Medicine Peer Reviewed Publication – “Inhalation of Sodium Pyruvate to Reduce the Symptoms and Severity of Respiratory Diseases Including COVID-19, Long COVID, and Pulmonary Fibrosis
Inhalation of Sodium Pyruvate to Reduce the Symptoms and Severity of Respiratory Diseases Including COVID-19, Long COVID, and Pulmonary Fibrosis
Submitted and accepted in the peer reviewed European Journal of Respiratory Medicine
Overview
To combat the continuing COVID-19 pandemic, and to treat the symptoms in long COVID (hypoxemia (low SaO2), fatigue, coughing/sneezing, trouble breathing, body aches, headaches and pulmonary fibrosis), N115 (sodium pyruvate) was chosen because of its safety and efficacy profile after treating 3.5 million patients in over 200 hospitals globally with no adverse events reported.
In 19 Phase I, II, III FDA human clinical trials, against a saline placebo, only N115 reduced inflammation and oxygen radicals and inflammatory cytokines including IL-6, a cause of the cytokine storm in patients with an active COVID-19 infection.
In prior clinical trials, N115, not the saline placebo, reduced congestion and coughing while increasing lung functions, increasing the synthesis of NO, and increasing SaO2 levels in thousands of patients including patients with varying lung diseases like COPD, Pulmonary Fibrosis (PF), Cystic Fibrosis, Allergic Rhinitis, Sinusitis and Influenza infected patients.
Numerous studies have shown oxidative stress to be associated with Pulmonary Fibrosis, including Long COVID patients with Pulmonary Fibrosis, and that antioxidants are effective in attenuating fibroproliferative responses in the lungs of animals and humans.
Sodium Pyruvate is a natural antioxidant of the human body that inhibits Fibrosis and we received Orphan Drug Designations for the treatment of Cystic Fibrosis and Pulmonary Fibrosis. The objective of the clinical trials reported here was to study the safety and efficacy of N115 and changes in lung function and COVID symptoms in acute virally infected COVID-19 patients, patients with chronic symptoms after COVID-19.
Background:
To combat the continuing COVID-19 pandemic, and to treat the symptoms in Long COVID patients with a safe, effective, and inexpensive treatments are needed. Patients recovering from severe COVID-19 are at serious risk of developing Pulmonary Fibrosis.
Conversely, patients with Pulmonary Fibrosis have an increased risk and susceptibility to COVID-19 infection, demonstrating the need to treat both.
Design:
Three separate Phase III Clinical Trials were conducted by Cellular Sciences (the research arm of EmphyCorp Inc.) with COVID-19 infected Patients, Long COVID (Long Haulers) Patients, and in Patients with Pulmonary Fibrosis to determine the efficacy of N115, a sodium pyruvate based Nasal Spray. Patient symptoms, vital signs and respiratory function were evaluated compared to a placebo control or a no treatment baseline control.
Findings:
During active COVID-19 infection, N115 decreased viral titers and produced a statistically significant improvement over saline in coughing/sneezing and fatigue. N115 lowered viral titers to below 10,000 by day 6.4 versus day 7.7 for saline, versus 10.4 days for untreated controls.
As titers below 10,000 reduce the transmission of COVID-19, this may help decrease virus spread in N115 treated patients.
In Long COVID Patients, N115 produced statistically and clinically significantly improvements to reduce, headaches, coughing/sneezing and increased SaO2 levels (decreased hypoxemia) and improved breathing (dyspnea).
In Patients with Pulmonary Fibrosis, there was a significant improvement in all lung functions, compared to baseline, as determined by changes in SaO2, FVC, FEV1, PEF, and FEV1/FVC ratio.
Conclusions:
N115 is safe and effective at reducing symptoms of active COVID-19 infection and improves disease condition in Long COVID patients.
Furthermore, N115 significantly improves lung function in Pulmonary Fibrosis Patients.
As COVID-19 and Pulmonary Fibrosis are associated with each other, our clinical research demonstrates that N115 is a promising treatment for both and adds to the current 19 human clinical trials where N115 has shown efficacy in thousands of patients, regardless of the etiology of the lung disease (COPD, CF, Allergic Rhinitis, Sinusitis, Flu, COVID-19 infected patients, Long COVID and Patients with Pulmonary Fibrosis).
Clinical Trials Results for COVID-19, Long COVID, and Flu are on ClinicalTrials.Gov:
N115 Nasal Spray Phase III Clinical Trial - Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers (Long COVID)
https://clinicaltrials.gov/ct2/show/NCT04871815?term=cellular+sciences&draw=2&rank=2
N115 Nasal Spray Phase III Clinical Trials - Sodium Pyruvate Nasal Spray Treatment of COVID-19 and Influenza Infections
https://clinicaltrials.gov/ct2/show/NCT04824365?term=cellular+sciences&draw=2&rank=1