Benzinga | Jun 28, 2021 08:55AM EDT

Aytu BioPharma Announces Peer-Reviewed Publication Of Clinical Results From Healight(TM) Pilot Study

Aytu BioPharma, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today that data from the first in-human, open label, clinical trial studying the safety and effectiveness of ultraviolet A (UVA) light endotracheal catheter therapy was published online on June 26, 2021 in the peer-reviewed journal Advances In Therapy. The UVA light catheter technology utilized in this study is the basis of Aytu BioPharma's Healight(tm) medical device which has been exclusively licensed worldwide for all endotracheal and nasopharyngeal applications.

The study titled, "Endotracheal application of ultraviolet A light in critically ill patients infected with severe acute respiratory syndrome coronavirus-2: A first-in-human study of internal ultraviolet A therapy" 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 daily UVA light therapy for five consecutive days at a single U.S. center. The UVA light catheter was inserted into the patients' endotracheal tube (ETT) and illuminated for 20 minutes with 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 10-point 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 severity scores improved by 4.75 points on day 30. Importantly, no serious adverse device effects or early treatment discontinuation was observed in the study.

Josh Disbrow, Chief Executive Officer of Aytu BioPharma, commented, "These important proof-of-concept first-in-human clinical trial data for the technology underpinning the Healight technology have now been peer-reviewed and published. This pilot study shows the potential clinical utility in treating mechanically ventilated SARS-CoV-2 patients and sets the stage for a larger, sham-controlled clinical study soon to be underway in Europe. That study will include significantly more patients in a well-controlled, randomized clinical trial, and we expect that study to begin in the first quarter of fiscal 2022."

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

The peer-reviewed publication can be accessed via the link below:

https://link.springer.com/article/10.1007/s12325-021-01830-7