Clinical Study Begins for the First Oral Systemic Nitric Oxide Based Therapeutic for African Americans with COVID-19
This is the first and only COVID-19 study specifically addressing the health disparities in African Americans - one of the most affected, high-risk populations of the virus.
Oct 26, 2020, 08:53 ET
AUSTIN, Texas, Oct. 26, 2020 /PRNewswire/ -- Nitric Oxide Innovations (NOI), LLC has received Investigational New Drug (IND #150758) clearance as part of the Coronavirus Treatment Acceleration Program (CTAP) from the U.S. FDA to begin a Phase 2b/3a outpatient clinical study testing the safety and efficacy of its new drug, NOviricid, 30 mg sodium nitrite dosing in an oral lozenge. NOviricid is the first oral Nitric Oxide (NO) generating drug to be clinically tested to treat African Americans diagnosed with COVID-19. www.clinicaltrials.gov (NCT04601077)
NOviricid offers a fast acting, Nitric Oxide therapeutic, with proven vasodilatory and anti-viral properties, targeting the effects of the novel Coronavirus. NOviricid is a proactive treatment, to be administered at the early onset of symptoms to prevent the rapid progression of the virus, improve recovery and survival of African Americans or anyone who is symptomatic. NOviricid promises an easily administered, safe, affordable, and effective treatment.
MULTI-CENTER TRIAL
840 African American patients testing positive for COVID-19 within the previous 72 hours, will be selected for participation. Study participants must present with one or more comorbidities (high blood pressure, COPD, heart failure, diabetes, obesity, etc.) and will participate in a double-blinded, placebo-controlled study to determine the effectiveness of NOviricid. All study patients will be provided digital pulse oximeters and blood pressure monitoring equipment. These devices will be monitored remotely for changes in their oxygen levels. Primary endpoints are hospitalization, need for ventilation, and death.
To date, the COVID-19 pandemic has infected over 36 million people worldwide and is responsible for over 1 million deaths. In the U.S., African Americans are one of the most affected, high-risk populations. According to the Centers for Disease Control and Prevention (CDC), African Americans experience a 2.8x higher infection rate, a 4.7x higher hospitalization rate and 2.1x higher death rate than Caucasians. Those with comorbidities such as hypertension, diabetes, obesity, history of smoking, kidney disease and respiratory illnesses are most at risk for infection and rapid progression of the disease.
Dr. Nathan S. Bryan, Founder and CEO of NOI states, "Everything we have learned about COVID-19 over the past 10 months reveals that diminished nitric oxide production in patients is what is thought to be responsible for the increased risk of infection and rapid disease progression. This applies directly to the African American population, which often suffers from diminished nitric oxide production. A lack of nitric oxide explains the multi-system disease and dysfunction that persists long after the active infection is gone, including increased risk of blood clots, endotheliitis, kidney and lung dysfunction. Restoration of nitric oxide appears to be a very safe and effective solution."
In recent, and ongoing, studies using nitric oxide, it has been shown that nitric oxide inhibits Coronavirus replication. While inhaled nitric oxide has been used very successfully to treat critically ill patients on ventilators, it is expensive and difficult to deliver outside of the hospital setting making it impractical to treat patients recently diagnosed with COVID-19. By contrast, NOviricid, an orally disintegrating nitric oxide therapeutic, is administered before the patient is critically ill, ideally within 72 hours of a positive COVID-19 test. We believe that early intervention with NOviricid will prevent hospitalization, the need for ventilation and death. NOviricid is the first therapeutic in our long line of drug candidates."
Bob Arnot M.D., NOI Chief Medical Officer, says: "Although severe COVID-19 infections can lead to Acute Respiratory Distress Syndrome (ARDS), its vascular effects should not be overlooked. COVID-19's effects on the vascular system affect the brain and heart and can lead to lethal effects on the blood clotting system. A key underlying mechanism of COVID-19 appears to be vascular endothelial dysfunction which explains the increased risk of infection and rapid progression of disease. This makes the restoration of nitric oxide a key strategy for the early treatment of COVID-19, especially in those with pre-existing conditions. Nitric oxide has been proven to be a potent vasodilator for small blood vessels, supplying healthy alveoli and potentially reducing the AV shunt seen in COVID-19 patients with severe ARDS on ventilators. NOI's IND clearance from the FDA allows us to quickly explore this promising therapeutic avenue. This will be a game changer when it comes to COVID-19 therapeutics".
NOI's outpatient study will collect real time data via eCare21's telemedicine platform to identify disease progression in at-risk patients. Nitric oxide drug therapy will address all of the underlying risk factors for African Americans with COVID-19 and help protect them from the long-term complications, including risk of blood clots, embolism, heart attack and stroke.
There are currently 4 clinical sites, enrolling up to 350 patients each, throughout the United States. Sites located in Chicago, IL; Houston, TX; Augusta, GA; and Jackson, MS will continue to enroll patients until the study reaches 840 participants.
Premier Urgent Care, located in the South Side Hyde Park area, is the clinical medical site representing Chicago, IL. Managing Partner and CEO, Michael A. McGee, M.D. states, "This is a very important study in helping to prevent hospitalization and death in high-risk African American patients with comorbidities. In fact, this is the first and only COVID-19 study specifically addressing the health disparities in people of color that seeks to prevent worsening short-term complications as well as long-term adverse effects."
Patient enrollment has already begun and will continue until all subjects have completed the study. If the trial proves the anticipated positive clinical outcomes, NOI will apply for a new drug application from the FDA at the end of the study. NOI is one of only 350 companies that have received review and clearance for an Investigational New Drug application as part of the CTAP.
About Nitric Oxide Innovations, LLC:
Founded in 2018, Nitric Oxide Innovations was established to commercialize clinically and scientifically proven NO based technologies for a wide range of human diseases and conditions. NOI's mission is to be the industry leader and innovator of nitric oxide-based therapeutics, Nitriceuticals, and for the safe and effective treatments of a variety of human diseases. Focusing on proven nitric oxide patented technology, along with patented innovative delivery systems, Nitric Oxide Innovations LLC will develop novel drug therapies ranging from topical drug deliveries to oral formulations for specific drug indications where safety and efficacy are already established. These new nitric oxide therapies will address pulmonary hypertension, non-obstructive but ischemic coronary artery disease (INOCA), heart failure with preserved ejection fraction (HFpEF) and chronic wound/ulcer therapy. www.nitricoxideinnovations.com
NOI strives to become the global leader in nitric oxide product development by leveraging its patented technology, science, and research to create the first safe and effective therapeutic drug to treat patients suffering from Covid-19. For more information, please contact [email protected]
Contact: Janice McCafferty
Janice McCafferty Communications
(773) 736-9034 – Direct
[email protected]
SOURCE Nitric Oxide Innovations (NOI), LLC
