Imagine a technology so innovative and groundbreaking in its potential impact that its sponsor is calling it “a moonshot” and “an opportunity so big you could build an entire company around it”. Yet despite that lofty aspiration, there has been scant media attention devoted to a potential medical breakthrough that could have epochal implications for healthcare; Covid and beyond.
The sponsor referred to is Josh Disbrow, Chairman and CEO of Aytu BioScience, a small, Colorado-based specialty pharmaceutical company focused on commercializing novel medical products. The product he is referring to is the patented Healight Platform Technology, a small catheter that can be inserted down the throat of an intubated, critically ill coronavirus patient. In more formal terms, the Healight device is a novel endotracheal catheter emitting ultraviolet light that has demonstrated broad antimicrobial activity in published preclinical studies.
Last April, Aytu announced the global licensing of the Healight technology platform from the distinguished Cedars-Sinai Medical Center in LA. Mr. Disbrow believes Healight has great potential as a first-in-class treatment for severely ill patients intubated in the ICU and, in the near-term, as a potential COVID-19 treatment for those most severely ill patients.
“We see broad potential application well beyond Healight’s use in COVID,” Mr. Disbrow said when speaking to investors last week, “including ventilator associated pneumonia, severe influenza and other infections.”
Aytu is currently seeking accelerated FDA approval under the Emergency Use Authorization (EUA) so Healight might be used to potentially save the lives of critical coronavirus patients. If Healight proves effective it could be a major game-changing, widely-used medical technology.
“As UV light is agnostic, so to speak, to the pathogens it kills, and is so different in the way it does it, the antimicrobial applications for Healight are broad.” Mr. Disbrow stated. “With such a broad set of potential clinical applications, we envision Healight, if successful, to become an important tool in hospital ICUs around the world. Antimicrobial resistance is a global problem and attacking it in a nontraditional way may prove to be a better way to treat difficult infections and rely less on traditional antibiotic and antiviral therapy.”
Light therapy is not new. Researchers are simply building on decades’ worth of science to determine whether the novel coronavirus could be treated or destroyed through the power of light. Scientists believe the light therapy affects cells producing a reaction that allows them to function more normally. In the case of COVID-19, that may help dampen down immune system overreaction that leads to often deadly “cytokine storms.”
“So what light therapy can do is activate pathways that would stop cells from dying, which is also useful when you’ve got something like COVID-19 destroying cells all over the body,” says Michael Hamblin, a former associate professor at Harvard Medical School, in a recent article by the CTV News Network.
Early studies suggest that some forms of light appear to destroy coronaviruses in the lab setting. The Medically Associated Science and Technology (MAST) program at Cedars-Sinai has been working on various applications of UV light for years. In a comprehensive and promising study by the influential non-profit research organization PLOS over the summer, multiple methods were tested to determine how effective UVA light was for treating different types of microbes. The tests were conducted both in-vivo and in-vitro, or more simply, inside and outside the body.
For in-vitro testing, researchers in the study conducted a variety of UVA light applications on human cells infected with the coronavirus. Following the test, researchers were able to determine that human cells treated with the UVA light were significantly better off than cells that had been treated with nothing.
There were two main effects of the UVA light on the coronavirus. First, the UVA light reduced cell to cell transmission of the virus by destroying the protein spikes that allow the coronavirus to spread. At the same time, coronavirus induced cell death was significantly reduced, meaning the virus will cause less damage to the body overall when treated with UVA light. Additionally, the UV light had no cancer-causing effects as some had feared. This proved what many health experts already believed, that UV light for coronavirus, and any microbes for that matter, is an effective treatment.
For the in-vivo testing, researchers took several different species of rat and exposed them to intracolonic UVA light, inserting a diode emitting UV light into the intestines of the rat. After the treatment, it was shown that the rat had significantly decreased levels of harmful bacteria present with little negative health effects on the rat.
From the results of both the in-vitro and in-vivo testing on human cells and rats, researchers concluded that these findings suggest, “under specific conditions, UVA reduces various pathogens including coronavirus-229E, and may provide a safe and effective treatment for infectious diseases of internal viscera.” In other words, internal UV light might just be an effective treatment for coronavirus and other viruses.
It must be noted that no form of light therapy has yet been proven to work against COVID-19. Some forms of UV light can be harmful and can trigger burns, which could lead to more significant health issues. So, to definitively answer the question of whether this technology has any practical use in treating coronavirus outside of a tightly controlled lab environment, Aytu and their partners moved quickly to interface with the FDA, who approved Healight for clinical trials involving humans under the leadership of Cedars-Sinai. Called simply: “UVA Light Device to Treat COVID-19”. This initial small-scale trial got underway in October to test the Healight technology on five COVID-19 patients on ventilators to see if it will lessen the viral load and disease severity.
Aytu has already done a fair amount of work at this early stage. They’ve formed a scientific advisory board with infectious disease, pulmonary and critical care experts from around the world and, from a commercial development standpoint, have engaged with prospective partners to evaluate the opportunity. Aytu engaged Sterling Medical, who has an unblemished track record facilitating FDA approvals, to design and develop the prototype that is being used in the trials. Efforts have also begun to source the relatively small but scalable manufacturing as well as determine what the costs are going to be going forward. Once trial results are published in December, a larger scale study can be conducted along with continuing the discussions from a regulatory standpoint.
“We still need to understand everything that we have here…but we’re optimistic that it’s going to prove out to be a product that has good clinical promise. And obviously, we’ll build-out a commercial plan and infrastructure accordingly,” Mr. Disbrow acknowledged.
Aytu has licensed the global rights to not just esophageal and tracheal applications but also nasopharyngeal applications. This means that for patients that may present very early with a severe infection like COVID-19, Healight can provide an ability to potentially treat those patients with something going through the nasopharynx.
“We view this as a relatively straightforward and very cost-effective add-on for a patient that’s intubated already in the ICU and [who is] very costly to the system,” Mr. Disbrow points out.
The theoretical potential is lucrative when you consider the daily cost of an ICU patient. The ability to add something as cost-effective as Healight to improve outcomes, minimally reduce viral and bacterial load, and potentially improve outcomes to the point of minimizing number of days within the ICU, i.e. getting patients to discharge faster, could save the healthcare system a lot of effort and cost. The value proposition there is enormous, even just on the basis of simply adding it on to what is already a very expensive resource-intensive in-patient treatment. Include in that the build-out of applications in the outpatient setting and Healight could be a goldmine, but something that Aytu hasn’t yet put all of the specific clinical protocols around.
“It’s very exciting to think about because that’s a huge number of patients. And as you think about broad applications again and beyond the critical illness like COVID, which obviously the application for a patient presenting with a severe respiratory illness in the emergency room, that’s a significant number of patients.”
There are many more patients in the ER than end up in the ICU so the application opportunity is much larger there. That opportunity gets even larger when you think about patients that have chronic infections, chronic rhinosinusitis, chronic bacterial infections, and chronic bronchitis, to name a few. These are patients who typically run the gamut with respect to the number of antibiotic courses that they’ve already undergone.
Mr. Disbrow is excited by Healight’s potential but he is careful to take it one step at a time. “We think there’s a near-term opportunity to gain proof-of-concept here in the intubated inpatient setting and…expand out from there as appropriate…a lot of potential to say the least.”
This first of its kind clinical trial is a single site study initially, but Aytu and Cedars-Sinai are already planning to extend the study to additional sites. Results from the clinical data are expected in December. If successful, the development team will move forward with further regulatory discussions and add in additional clinical sites including globally, with Mr. Disbrow confirming they have already engaged with leading centers in Europe.
In regard to all of the secrecy around Healight, Mr. Disbrow implies that this is part of a deliberate strategy.
“We have not provided up to the minute updates on Healight and that in no way means substantial progress is not being made. Quite to the contrary. A lot has been done with Healight in a very short period of time. We’re moving at a rapid pace, to say the least. But out of a strong sense of respect for our study partners and all of those involved, we are keeping the Healight updates to the most relevant milestones. This is important to preserve the integrity of the study and to ensure we keep the focus on making good steady progress.”
Mr. Disbrow leaves us all longing for more details from this promising Healight technology but provides this simple guidance, “You’ll be made aware of the relevant developments. For now, just know that very good progress is being made.”