The specialty pharmaceutical company Aytu BioScience, Inc. (NASDAQ: AYTU) has been seeing its share price rising 9.84% in the pre-market session today following results of its first-in-human clinical trial for the treatment of COVID-19.
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What does the study reveal?
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Aytu BioScience focuses on the development of novel products to address significant patient needs and bring them to the commercialization stage. Aytu currently markets a portfolio of prescription pharmaceutical products for the primary and pediatric healthcare markets. A portfolio of the products includes Natesto, ZolpiMist, Tuzistra XR, Karbinal ER, Poly-Vi-Flor, and Tri-Vi-Flor.
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The company also distributes COVID-19 IgG/IgM rapid antibody tests as well as rapid COVID-19 antigen tests. Diagnostic testing is carried out separately using the two tests to ensure proper diagnostic assessment of the 2019 Novel Coronavirus. Further, Aytu owns the global rights to the Headlight technology platform which the researchers are studying as a prospective treatment for COVID-19 and other respiratory infections.
The first open-label, in-human clinical trial results from the Aytu BioScience in SARS-CoV-2 patients was released on Monday. The pre-print publication was titled:
“Endotracheal application of ultraviolet A light in critically ill severe acute respiratory syndrome coronavirus-2 patients: A first-in-human study”
- This study concluded that endotracheal UVA treatment was associated with a significant drop in virus load and improvement in WHO clinical severity scores in patients with SARS-CoV-2.
- Moreover, patients responded well to endotracheal UVA light treatment and did not experience any serious side effects.
- During the study, five critically ill COVID-19 patients were exposed to UVA light treatment for five consecutive days.
- Each treatment was carried out by using the UVA light catheter inserted into an endotracheal tube (ETT) and enhanced for 20 minutes.
- Treatment with endotracheal tube resulted in a significant logarithmic reduction of the CoV-2 virus load in ET aspirates, the study’s primary endpoint.
- A log change of -2.41 and -3.2 was recorded for day five and day six.
- Clinical severity scores revealed moderate improvement in WHO clinical severity scores, i.e. 1.6 on day 15 and 3.6 on day 30.
- The WHO clinical severity scores increased by 4.75 points on day 30 after excluding subject two, who had an undetectable viral load.
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- Significantly, no serious adverse device effects were observed, and treatment did not have to be discontinued prematurely.