Benzinga | Mar 8, 2021 04:02PM EST

Aytu BioScience Announces Clinical Results From Healight Pilot Study In SARS-CoV-2; Says 'Data indicate endotracheal UVA light catheter therapy reduces SARS-CoV-2 viral load and improves clinical outcomes in mechanically ventilated SARS-CoV-2 patients'

Data indicate endotracheal UVA light catheter therapy reduces SARS-CoV-2 viral load and improves clinical outcomes in mechanically ventilated SARS-CoV-2 patients

ENGLEWOOD, CO / ACCESSWIRE / March 8, 2021 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today that data from a first in-human, open label, clinical trial in SARS-CoV-2 patients has been released.

The pre-print publication titled "Endotracheal application of ultraviolet A light in critically ill severe acute respiratory syndrome coronavirus-2 patients: A first-in-human study" concluded that endotracheal UVA light treatment was associated with a significant reduction of SARS-CoV-2 viral load and improvement in WHO clinical severity scores. Additionally, the endotracheal UVA light treatment did not result in any serious adverse device effects and was well tolerated.

A total of five critically ill, mechanically ventilated COVID-19 patients underwent UVA light therapy for five consecutive days. The UVA light catheter was inserted into an endotracheal tube (ETT) and illuminated for 20 minutes during each treatment. The endotracheal (ET) treatment resulted in significant logarithmic reduction of the SARS-CoV-2 viral load of the ET aspirate, which was the study's primary endpoint. Average log changes from baseline to day five and day six were -2.41 (>99%, p=0.0018) and -3.2 (>99.9%, p=0.0005), respectively. WHO clinical severity scores improved by an average of 1.6 and 3.6 points on day 15 and day 30, respectively. Excluding subject two, who had undetectable viral load, WHO clinical severity scores improved by 4.75 points on day 30. Importantly, no serious adverse device effects were observed, and no early treatment discontinuation occurred.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We believe the Healight technology can become an important tool for fighting the global COVID-19 pandemic, and we look forward to continuing discussions with the FDA on the advancement of this technology. There may be additional anti-infective applications for Healight beyond COVID-19, so having this initial proof of concept data gives us a great deal of enthusiasm for the potential of this investigational device. I would like to thank the team and our collaborators for the work that went into conducting this study and generating this data."

Aside from coronavirus, utilization of internal UVA light may have numerous other respiratory applications. Aytu BioScience will continue to engage with researchers in multiple therapeutic areas to continue to build on this technology platform.

The data have been published in MedRxiv, an online archive for health science pre-print manuscripts that are not yet peer reviewed. The manuscript has been submitted for peer review.