DURHAM – Last week, EmitBio announced study results that showed that its blue light biotechnology could eliminate 99.99% of the coronavirus that causes COVID-19, including the Omicron variant.
“Our device is the only non-systemic solution based on technology proven to have no loss in potency against any variant tested in the lab,” said David Emerson, Ph.D., CEO of EmitBio in an exclusive interview with WRAL TechWire. “We are optimistic about widescale deployment of our variant agnostic approach.”
Emerson noted that there’s an “expectation of the same in our second human trial,” and the company anticipates results later in the first quarter of 2022.
While other approved treatments have had their emergency use authorizations removed due to their inability to combat the Omicron variant, EmitBio’s technology is effective in 99.99% of cases, accordingto Emerson.
David Emerson, CEO of EmitBio. (EmitBio image).
Further, said Emerson, the company’s technology can “be used at home,” which results in patients gaining control over effective treatment.
There’s an immense need for effective treatment of COVID-19, said Emerson, noting that some 2,000 Americans each day are passing away.
“There remains an emergency to make more treatments available,” said Emerson. That’s true across the globe, and Emerson told WRAL TechWire that with the strong financial support of the company and its technology, the company is planning for how it could bring its technology to market to assist patients across the globe.
“Our goal is to make this treatment available globally as rapidly as possible,” said Emerson. To do this, the company will likely seek a combination of financing, partnerships, and licensing agreements, Emerson noted. Importantly, said Emerson, the company’s treatment for COVID-19 can be used alongside other existing and future therapies.
A transcript of WRAL TechWire’s interview with Dr. Emerson appears below, and has been lightly edited for clarity.
Study: EmitBio’s blue light biotech can eliminate 99.99% of Omicron in lab setting
What happens next
WRAL TechWire (TW): The latest laboratory results confirmed that the technology developed by EmitBio is 99.99% effective at eliminating the Omicron variant of the coronavirus that causes COVID-19. What next steps is the company taking, and what is the timeline for those steps?
Dr. David Emerson, CEO, EmitBio (Emerson): More tools are needed to end the COVID-19 public health emergency, and we are continuing development of our biotechnology platform with the same intensity we have had since the start of pandemic.
First, we are building support in the scientific, medical, and public health communities for our novel approach. For example, both our pre-clinical findings and clinical results have recently been validated through publication in peer reviewed journals. Several more manuscripts are under review.
Second, we are continuing to test our approach in the clinic. In December, we completed a double-blind, placebo-controlled trial of the RD-X19 device with more than 200 participants with mild to moderate COVID-19. In this trial, we incorporated helpful FDA feedback given in response to engagement on our first early feasibility study. Readout is expected in the first quarter of 2022, and additional trials are planned.
Third, we are preparing to reengage with the FDA on appropriate deployment of the technology, whether through Emergency Use Authorization or some other pathway.
Fourth, we are solidifying our supply chain so that when we do receive clearance, we can minimize the time to making this important treatment modality broadly available. In short, we are preparing for rapid, wide scale deployment of our biotechnology platform during 2022.
At EmitBio, we have the opportunity to apply our novel, light-based biotechnology not only to the treatment of mild-to-moderate COVID-19, but also to a broad range of diseases and disease states. We have built prototypes for applications ranging from general wellness to pre-exposure prophylaxis to critical care for COVID, influenza, and pneumonia. In addition, while we prepare for the launch of our first product, we are continuing to strengthen our fundamental intellectual property portfolio which covers both our devices and the underlying biotechnology platform.
What about other variants?
TW: What can you share with us about the effectiveness against other known variants – and based on these results, and the underlying technology and genetic composition of the virus, what reasons are there to believe the technology can and will be effective against future variants?
Emerson: The treatment is designed to be mutation resistant. It is not designed to be dependent on a specific SARS-CoV-2 genetic code or configuration of the spike protein. Significantly, our technology has exhibited no loss in potency against any SARS-CoV-2 variant tested to date – including wildtype, alpha, beta, gamma, lambda, delta, and omicron.
Experiments in our laboratory indicate that our treatment platform is neither antigen-directed nor antigen-dependent, affording a novel therapeutic approach that can be widely deployed to mitigate the threat posed by current SARS-CoV-2 variants, pre-emergent variants, and potentially other non-coronavirus pathogens.
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The latest data
TW: What’s the latest data show or confirm? What are you and your team looking for in laboratory studies?
Emerson: The latest data shows that EmitBio’s technology is 99.99% effective at eliminating the Omicron variant of the coronavirus that causes COVID-19. We have seen similar results in both cell-free and proprietary human airway tissue models. This result further validates EmitBio’s photobiomodulation approach, the biotechnology platform, and the treatment.
In laboratory studies, we look to see strong reduction of the virus in vitro, typically greater than 99.9% in standard assays. We have seen this level of reduction or greater against all SARS-CoV-2 variants tested to date. In contrast, recent reports show that select monoclonal antibody therapies can be more than one-thousand times less effective against Omicron, leading to the decision by the FDA to limit emergency use of certain antibody therapies which have no impact on the variant.
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Blue light treatment
TW: Why this is so important – and why is the company’s technology well-suited for fighting the pandemic?
EmitBio’s blue light treatment option provides the only non-systemic approach demonstrated to be variant agnostic for coronavirus in the laboratory setting. This treatment has been equally effective, with no loss in potency, against any of the variants tested to date.
From a disease treatment standpoint, we believe that the EmitBio biotechnology platform has potential utility to control acute SARS-CoV-2 infections, reduce symptomatic disease and viral load, and may reduce person-to-person transmission after infection. All of these outcomes can help to disrupt the viral replication chain, slowing the spread of disease, reducing cases, saving lives, and reducing healthcare costs.
From a pragmatic standpoint, the RD-X19 device, based on the EmitBio biotechnology platform, has been designed for high volume manufacturing, deployment through normal distribution channels, self-administration at home, and stockpiling for future need. This technology could have utility not only during the public health emergency, but also when the COVID-19 pandemic transitions to endemic stage.
Non-Covid applications
TW: What other use cases and applications have you identified for the technology?
Emerson: EmitBio has discovered how to use precise, monochromatic wavelengths of visible light to eliminate invading pathogens and stimulate host defense in the body. For COVID-19 and other respiratory diseases, we believe this approach could be used in applications spanning general wellness as a daily immune booster to critical care where therapeutic doses of light can be deployed into the lungs.
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The RD-X19
TW: Why could a local treatment work for a systemic disease? Why are more treatments needed?
SARS-CoV-2 infects the oral cavity, upper respiratory tract, and large airway prior to spread to the lower respiratory tract and the late-stage development of acute respiratory distress. Sustained replication in the oral and nasal cavities is likely a key contributor to the increased transmissibility of SARS-CoV-2 compared to other coronaviruses. For these reasons, a targeted, local treatment for acute SARS-CoV-2 infection of the upper airway epithelia to halt progression via the oral-lung transmission axis may help to resolve systemic disease.
The RD-X19, based on EmitBio’s biotechnology platform, is designed to work by directing precise wavelengths of visible blue light to the oropharynx and surrounding tissues at the back of the patient’s throat to kill virus and trigger an immune response. In an early feasibility clinical trial, the treatment reduced viral load as measured in saliva by 99.9% and resolved symptoms 2.4 days faster when compared to a placebo.
The rapid development and deployment of vaccines, improved standards of care, and increased focus on therapeutics have helped slow the spread of SARS-CoV-2 and the resulting worldwide health and economic burden. However, pockets of uncontrolled viral spread have led to the emergence of novel variants like Delta and Omicron that are able to evade existing vaccines and therapeutics. It is expected that more will arise.
Accordingly, novel therapeutics that will work broadly against all variants, including those that have not yet emerged, are needed. EmitBio’s pre-clinical and clinical findings indicate that visible blue light may provide the only non-systemic, at-home treatment option for COVID-19 that works on all coronavirus variants.
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Next steps.
TW: What are your next steps?
Emerson: In the last two years, the EmitBio rapidly progressed from an idea on a whiteboard, through early-stage pre-clinical pathfinding, to multi-generational device development, and through three clinical trials.
Our next step is to deploy the technology that we have already developed and are testing in the RD-X19 device broadly during 2022.
Beyond that, we are expanding our fundamental intellectual property portfolio and have a robust product pipeline.
We have several issued patents and have filed more than twenty additional patents covering both the underlying approach and the clinical application. In addition, we have built prototypes for applications spanning applications from general wellness to pre-exposure prophylaxis to critical care and for other respiratory diseases including influenza and pneumonia. We aim to make this new treatment modality available to provide options, improve outcomes, and change the way the world thinks about respiratory disease.
EmitBio’s future
TW: What else can you tell us about the company’s future, and how this technology could be used?
Emerson: We have great partners who have helped to fund EmitBio to progress rapidly from whiteboard to clinic. Looking forward, we have the opportunity to apply our novel, light-based biotechnology platform far beyond COVID-19 to provide options that can improve the quality of life for conditions from respiratory disease to wound care, cognitive function, cancer and beyond. We are always looking for the right relationship to make this new treatment modality equitably available as rapidly as possible, whether through partnering, licensing, or investing.
There is a large community that would benefit from access to evidence-based alternatives to traditional pharmacologics, whether in addition to or replacements for those treatments.
Right now, many of the options are false promises that may not only harm patients but also the extended community. At EmitBio, we have the opportunity to apply our novel, light-based biotechnology not only to the treatment of mild-to-moderate COVID-19, but also to applications spanning the range from general wellness to pre-exposure prophylaxis to critical care and for other respiratory diseases including influenza and pneumonia.
We aim to make this new treatment modality available to provide options, improve outcomes, and change the way the world thinks about treating respiratory disease.
