EmitBio Seeks to Provide Light at the End of the COVID-19 Treatment Tunnel
Durham medical device company EmitBio Inc. thinks it has seen the light when it comes to treating COVID-19.
The company has reported positive clinical trial results for its initial 31-patient test of its investigational handheld rechargeable-battery-operated device. It works like a flashlight for the throat, which EmitBio has developed for at-home use, with a doctor's prescription, to shine targeted wavelengths of safe, visible LED light into the throat to attack bad bugs, including SARS-CoV-2, the coronavirus causing COVID-19.
The clinical trial included 31 male and female participants between the ages of 18 and 65 who tested positive for the SARS-CoV-2 virus and displayed early symptoms of COVID-19. The placebo-controlled, randomized and double-blind study was designed to measure the safety, tolerability and effectiveness of electromagnetic energy as a treatment for COVID-19.
Two-thirds of the trial subjects received four days of treatment twice daily from the light emitting device. The others were treated for the same amount of time with an inactive device.
Early results showed a more than 99% reduction of the SARS-CoV-2 viral load in saliva for those treated with the EmitBio product. The other participants had virtually no change in their viral levels. Metabolic, liver, kidney and blood laboratory evaluations also were performed. No adverse events were reported.
The company says the early trial shows the product not only dramatically reduces the amount of measurable COVID-19 virus, but also stimulates the body’s natural defenses. EmitBio said it is "in discussion" about its Emergency Use Authorization for the device with the U.S. Food and Drug Administration.
EmitBio told the North Carolina Biotechnology Center that the product prototype, made in North Carolina, bathes the back of the throat with a form of solid-state LED light that can get rid of most of the virus in people with mild to moderate COVID-19 infections. Patients also recovered from symptoms a couple of days sooner than participants in a control group.
Inactivates virus before it infects
EmitBio said its device can inactivate viral particles before they infect cells, as well as inhibit their later growth. The targeted light also releases natural reserves of nitric oxide and stimulates cells to produce more of the molecule, which is vital to the body’s immune response. Nitric oxide helps disrupt infection, slows viral reproduction and stimulates immune cells to attack and destroy invading disease agents like influenza and coronavirus.
“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,” said EmitBio Chief Scientific Officer Nate Stasko, Ph.D. “Even more notable, we saw viral load continue to drop even after the light treatments were completed. We believe that the massive decrease...we observed will also have a significant impact on secondary community transmission.”
The company said the therapy, if authorized for emergency use by the FDA, could be prescribed by doctors for at-home use by adult patients (18 and up) who exhibit mild to moderate symptoms of COVID-19.
EmitBio has produced this animated video to demonstrate how the treatment works.
“More than half the people who test positive for SARS-CoV-2 will either be asymptomatic or have a mild to moderate case of COVD-19,” said Neal Hunter, executive chairman of EmitBio. “As a country, we have to do better than ‘go home, quarantine and hope for the best.’ It’s a public health imperative that every person diagnosed with COVID-19 has a safe treatment option.”
Another Cary-based firm, Lumagenics, also is considering light – although of another type – to combat COVID-19. That company is exploring the use of ultraviolet radiation to kill SARS-CoV-2 and other pathogens on targeted surfaces via its CoolUV technology.
EmitBio depends on the precise delivery of light to stimulate, heal and protect the body. It currently focuses on advanced LED technology. The company is a subsidiary of Research Triangle-headquartered biotech KNOW Bio, a leader in the development of nitric oxide-based therapies.
KNOW Bio was created in 2015 as a spinoff of drug company Novan, which uses a nitric oxide science and technology platform to develop therapies for unmet medical needs.