Surgeons demonstrate the administration and use of Aytu BioPharma’s Healight endotracheal catheter system on a mechanically ventilated mannequin. Credit: Michael Lappen

Aytu BioPharma, a specialty pharmaceutical firm based in Englewood, Colorado, has developed an endotracheal respiratory catheter it says has “tremendous potential” to treat upper respiratory diseases such as idiopathic pulmonary fibrosis (IPF) and pulmonary arterial hypertension (PAH).

Josh Disbrow, chairman and CEO of Aytu BioPharma. Credit: Randall Photography

The patented device, known as Healight, has already been shown to significantly decrease the viral load in patients hospitalized with COVID-19, said Joshua Disbrow, chairman and CEO of Aytu.

The company is also developing AR101, a molecule also known as enzastaurin, to treat vascular Ehlers-Danlos syndrome (VEDS), a rare inherited connective tissue disorder. In addition, it already markets 2 therapies for attention-deficit/hyperactivity disorder (ADHD) in children.

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Treating COVID-19 Could Be Just the Beginning

Disbrow cofounded the company in 2015 with his twin brother, Jarrett. He said Aytu follows in the footsteps of 2 other pharma companies with which the pair were previously associated—Ampio and Arbor—hence the name A2, or Aytu.

“We’ve expanded quite rapidly,” Disbrow told Rare Disease Advisor, adding that Aytu generates about $100 million in annual revenue. “These assets we’re developing—Healight and AR101—are going to be global opportunities to enable us to expand our reach throughout the world.”

In 2020, Aytu obtained exclusive global licensing rights for Healight, which utilizes ultraviolet A (UVA) to treat endotracheal and nasopharyngeal conditions.

Conceived by a group of gastroenterologists at Cedars-Sinai Medical Center in Los Angeles, California, Healight uses tiny LED lights that surround an endotracheal catheter. This catheter is designed to go down the endotracheal tube in patients who have been intubated, are ventilated, and have a severe respiratory infection such as COVID-19 ventilator-associated pneumonia.

“Ultimately, it’s administered using a specific wavelength of light over a specific period of time, and it has shown to be very effective,” Disbrow said.

Insertion of the Healight endotracheal catheter within the endotracheal tube. Credit: Michael Lappen

“When the pandemic hit, many researchers and scientists pivoted to look at the potential application of this technology in COVID-19 to see if it could kill human coronavirus. It turns out that it could,” he explained. Subsequently, the company did a study with only a handful of patients, but, he said, “the proof-of-concept data were quite compelling.”

“Of 5 patients that were studied, 4 fully recovered by virtue of having the Healight technology onboard along with standard of care. That inspired us to move forward and do a larger study,” he said, adding that Aytu plans to expand that into a study of some 40 patients now being organized by pulmonologist Antoni Torres, MD, PhD, at Spain’s Hospital Clinic of Barcelona.

“We see a huge application in ventilator-associated pneumonia, which is certainly not as common as coronavirus but it’s deadly,” he said. “In patients on ventilators, pathogens get introduced from the external environment and ultimately get infected, and the prognosis for those patients is very, very poor.”

Using UVA to Stimulate Cell Signaling

Disbrow said it’s possible Healight will receive approval from the Amsterdam-based European Medicines Agency (EMA) before approval by the US Food and Drug Administration (FDA).

“UV light has tremendous potential. There’s this notion of cell signaling. If you can activate the mitochondria within the cells, then we believe you can do that specifically with UVA light,” he said. “There may be potential to significantly improve the immune response across a spectrum of cell types throughout the respiratory system, with application in some of those rare pulmonary diseases.”

Charles Dorsey, senior diagnostic director at Aytu, said UVA comprises about 98% of all UV radiation and terrestrial sunlight.

“It’s the least damaging to mammalian cells, so the Healight technology particularly utilizes UVA and the idea of light-emitting energy to disrupt and stimulate cell signaling. It is this cell signaling, in fact, that leads to the antiviral effect,” Dorsey said.

Patients with acute respiratory distress syndrome comprise about 10% of the patients in intensive care units, with about 23% of these patients on ventilators and facing significant mortality rates, he said.

“As we continue to see the proliferation of COVID‑19 increase, we believe the primary benefit of the Healight technology will shift from COVID‑19 treatment to viral and bacterial ventilator‑associated pneumonia conditions,” Dorsey said.

For now, such treatments can only be done in a hospital setting rather than as an outpatient procedure in a doctor’s office.

“The endotracheal catheter is inserted while a patient is under mechanical ventilation. It does require significant expertise and the highest level of triage care within the hospital system at this point,” Dorsey explained.

“The goal would be to obviously evolve the technology into something that would allow us to develop a nasal cannula by which, yes, that would be an opportunity to entertain early intervention prior to somebody reaching such a level of severity.”