Ultraviolet (UV) light has a long-standing track record in use as an antimicrobial. But the primary limitation to using UV light in relation to the human body is that it can also potentially damage its cells. A group of researchers at the Cedars-Sinai Medical Center in Los Angeles, Calif., known as the Medically Associated Science and Technology (MAST) team, has been investigating the potential application of the safest type of UV light within the body for years, particularly in gastrointestinal and genitourinary indications.

In the months since the start of the unfolding novel coronavirus pandemic, the MAST researchers pivoted to examining their technology in the context of treating the emerging disease. Then they out-licensed that work to small-cap specialty pharma company Aytu Bioscience Inc., specifically for endotracheal and nasopharyngeal indications. Aytu is now working with medical device engineering company Sterling Medical Devices, which was already collaborating with Cedars-Sinai, to finalize a prototype and pilot devices even as it sets up manufacturing.

UV into the body

“When COVID-19 struck, MAST, like so many researchers and companies around the world, pivoted. They worked night and day for weeks since the very beginning of the pandemic and engaged with Sterling Medical, who we've now engaged with, to develop a prototype device,” Aytu chairman and CEO Josh Disbrow told BioWorld.

“They needed to get it small enough, such that it can get down a trachea tube,” he added. “They continued to conduct the bench research looking at tracheal cells and demonstrating safety in animal models. When you look at epithelial cells, for example, they stay intact and healthy.” Epithelial cells line the inside and the outside surfaces of the body, including respiratory passageways in the lungs, as well as other organs and blood vessels.

The goal is to obtain emergency use authorization (EUA) from the FDA and then to begin treating COVID-19 patients starting mechanical ventilation, even as they collect clinical trial data. The only data thus far on the device technology, which is based on UVA light and is known as Healight, has been in cellular and animal models.

Cedars-Sinai researchers published a preclinical study in the United European Gastroenterology Journal in October 2019. The study did not find safety problems with use of UVA in the gut, suggesting that it could be used to treat microbial problems there.

It was the first study on an intracolonic UVA application. An additional peer-reviewed journal publication on preclinical COVID-19 data in mouse models from the Cedars-Sinai researchers is anticipated in the coming weeks.

UVA is one of three types of ultraviolet light, UVA, UVB and UVC. UVA has the longest wavelength of these and is thought to cause the least damage to cells in mammals, while also having a broad germicidal effect. UVA and UVB devices have been approved by FDA to treat some skin diseases including eczema and psoriasis.

How it could work

The Healight device for COVID-19 is being developed for use by insertion via the existing intubation in a mechanically ventilated patient. A catheter would be placed into the upper respiratory tract for routine treatments to kill the virus, as well as any other microbes such as those involved in pneumonia, in the surrounding cells. The hope is that this could aid the activity of the patient’s own immune system.

“Preliminary data has demonstrated coronavirus killing. The coronavirus resides in human tissues, specifically in the trachea and all the way down into the lungs,” said Disbrow. “It is thought to primarily reside in the upper airway, where if you can kill it early and kill it within the cells while preserving the healthy cells, that would be the golden ticket. The idea is that we would get this down the trachea, where the coronavirus is going to primarily reside, and then you have a chance to improve outcomes by reducing the viral load.”

The MAST researchers, led by Dr. Mark Pimentel, have been in discussions with the FDA for weeks already but any disclosure of a clinical trial design is pending an EUA from the agency.

"Our team has shown that administering a specific spectrum of UV-A light can eradicate viruses in infected human cells (including coronavirus) and bacteria in the area while preserving healthy cells," said Pimentel.

Added Ali Rezaid, “Our lab at Cedars-Sinai has extensively studied the effects of this unique technology on bacteria and viruses. Based on our findings we believe this therapeutic approach has the potential to significantly impact the high morbidity and mortality of coronavirus-infected patients and patients infected with other respiratory pathogens."

Capitalizing on COVID

Aytu has attracted a lot of attention of late, particularly from conservative media outlets, in the wake of comments late last week by U.S. President Donald Trump regarding the potential to introduce sunlight into the body to treat COVID-19 patients. Ultraviolet rays are a component of sunlight.

Founded in 2002, the Englewood, Colo.-based company focuses primarily on primary care specialty pharmaceutical products. Aytu had only $3.2 million in fiscal second quarter revenue, but in February it acquired Innovus Pharmaceuticals, which has a portfolio of more than 35 products with $24 million in annual revenue.

Healight is not the company’s first foray into the COVID-19 fray. It has been importing a rapid, qualitative test for use in blood, plasma or serum that detects IgG and IgM antibodies from Chinese developer Zhejiang Orient Gene Biotech Co. Ltd., which has not received an EUA from FDA. It is one of only a few tests used in China and is designed for point-of-care use that offers results in under ten minutes.

Only a handful of COVID-19 serological tests have secured an EUA from FDA, but more than 120 are reportedly being marketed in the U.S. under eased agency guidance. This proliferation of tests has drawn scrutiny, as the various tests are offering widely varying results.

The Chinese test is CE-marked and was the subject of a 113-patient study discussed in Infection Ecology & Epidemiology. It found that the test has an 87.9% sensitivity and 100% specificity for IgM, as compared to RT-PCR, with a 97.2% sensitivity and 100% specificity for IgG. Aytu has sold 100,000 of these tests.

More recently, Aytu also signed a deal with Singapore’s Biolidics Ltd. for its IgG/IGM rapid antibody test, which has been authorized for export from that country. It has agreed to buy 500,000 tests initially and at least 1.25 million tests over the first three months.

Investors have started paying attention, pushing the company (NASDAQ:AYTU) out of penny stock territory to a valuation of roughly $120 million. In early April, Aytu was able to raise $23 million in early in a warrant exercise, adding to its cash of $62.5 million as of March 31, 2020.

Summed up Disbrow on Healight, “Science doesn't vote. We're certainly not involved in anything from a political perspective, but it has certainly helped to get this device at least noticed. Prior to the President's comments, we were a small, relatively unknown biotechnology company. If nothing else, this has certainly enabled us to have a bit of a platform to showcase the technology.”

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