Aytu BioPharma Publishes on of Clinical Results from Healight(TM) Pilot Study

 Results Indicate That Endotracheal UVA Light Catheter Therapy is Associated with Significant Reduction in SARS-CoV-2 Viral Load and Improvement in Clinical Outcomes in Mechanically Ventilated COVID-19 Patients

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™ 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.

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