EmitBio Announces Positive Clinical Results Supporting A Novel Therapeutic For COVID-19
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EmitBio™ achieves 99.9% average viral load reduction with faster symptom resolution in adults with COVID-19; submits for Emergency Use Authorization
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DURHAM, N.C., Jan. 28, 2021 /PRNewswire/ -- EmitBio Inc., a life science company using the precise delivery of light to stimulate, protect and heal the body, today announced clinical results from its investigational treatment for adults with mild-to-moderate COVID-19.
In a placebo-controlled, randomized double-blind clinical trial, 4 days of treatment with the EmitBio device* achieved a 99.9% reduction in average viral load of SARS-CoV-2, the virus that causes COVID-19, and accelerated time to symptom resolution in patients by more than 48 hours compared to the control group. This transformational treatment uses a small handheld device that directs precise wavelengths of safe, visible, targeted light to the back of the throat and surrounding tissues. No treatment-related adverse events were reported in the trial. The device has been designed as an at-home treatment for mild-to-moderate COVID-19 in adults who have tested positive for the SARS-CoV-2 virus. These clinical study results followed thousands of in-vitro experiments and a Phase I safety study in healthy subjects which have all now been submitted as part of a comprehensive package to the FDA requesting Emergency Use Authorization.
"More than half the people who test positive for SARS-CoV-2 will either be asymptomatic or have a mild-to-moderate case of COVID-19. As a country, we have to do better than 'go home, quarantine, and hope for the best,'" said Neal Hunter, Executive Chairman, EmitBio Inc. "It's a public health imperative that every person diagnosed with COVID-19 has a safe treatment option."
"We saw 99.9% mean reduction of SARS-CoV-2, which represents three orders of magnitude – or a 1,000 times reduction – in viral load," added Nate Stasko, Chief Scientific Officer, EmitBio Inc. "Even more notable, we saw viral load continue to drop even after the light treatments were completed. The longer infected individuals go untreated, the greater the probability of disease progression with increased likelihood for viral transmission to others. We believe that the massive decrease in viral load we observed will also have a significant impact on secondary community transmission."
"Vaccines are a front-line necessity, and even though they have an incredibly high level of protection at over 90%, people aren't going to just return to normal daily living without regard for this virus," said Mike Knowles MD, Professor, UNC School of Medicine, Department of Pulmonary Diseases and Critical Care Medicine. "To have an at-home treatment available to use at the first signs of symptoms can help us all return to pre-COVID life."
EmitBio uses directed energy in the form of precise wavelengths of safe, visible light to eliminate pathogens and stimulate the body's natural defenses. In investigating light and power across the spectrum, the company discovered that safe, visible light effectively created an antiviral environment by inactivating viral particles before they infect the cell and inhibiting growth after.1 The EmitBio device directs treatment that is immediately available at the specific area of need. This avoids unwanted possible side effects of systemic treatments.
A key contributor to the antiviral activity of light is the EmitBio proprietary discovery that bathing human respiratory cells and tissue with safe, visible light releases natural reserves of nitric oxide as well as stimulates cells to produce more. Nitric oxide is vital to the body's innate immune response by helping to disrupt infection, inhibit viral reproduction and summon the immune cells to contain, attack, and destroy invading pathogens like influenza and coronavirus.2
"We have created a transformational technology and a product pipeline that can change the way the world protects against, and ultimately defeats, respiratory infections," continued Hunter. "This has driven what we believe is a fundamental patent portfolio. Our goal is to work with the FDA to get this treatment available to all those who need it whether through established distribution in the US or licensing the technology to global partners so that everyone has rapid access."
About EmitBio Inc. EmitBio Inc. is a life science company using the precise delivery of light to stimulate, heal, and protect the body. EmitBio is comprised of an experienced team of internationally recognized light science specialists merged with immunology and virology life science experts, prepared to react quickly to the pandemic and rapidly scale manufacturing for lifesaving medical breakthroughs. EmitBio™ is currently using advanced LED technology to create light that is fundamental to human health, harnessed for healing and for bodily defense. For more information, visit www.emitbio.com.
EmitBio Inc. is headquartered in Durham NC and is an operating subsidiary of KNOW Bio LLC.
* The EmitBio device is investigational and not currently available for sale.
- Supporting pre-clinical research was conducted with wild-type SARS-CoV-2 virus. The data was generated at two independent third-party laboratories with deep experience in antiviral research and used cell lines preferred by the coronavirus researchers. The full manuscript has been submitted for peer review.
- Garren et al. "Nitric oxide and viral infection: Recent developments in antiviral therapies and platforms," Applied Materials Today, 2021 (22), 100887.
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SOURCE EmitBio Inc.
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