APR Applied Pharma Research s.a. (APR), a leader in the development of pharmaceutical drug delivery technologies and systems and innovative products derived thereof, today announced the start of a pivotal clinical trial to assess the efficacy of its product temporarily codenamed APR-AOS2020, a Class III medical device, in the treatment of COVID-19 patients showing mild symptoms. The study is being conducted by the Hygiene Unit of IRCCS Policlinico San Martino Hospital in Genoa, Italy and coordinated by Prof. Giancarlo Icardi as lead investigator. The study is planned to enroll a total of 57 COVID-19 patients who show mild symptoms of the disease and is evaluating the efficacy and safety of the spray product in reducing viral load in the upper respiratory airways in recently infected individuals. Results, when available, could represent the starting point for the use of the product in the prevention of more severe symptoms, in the reduction of risk of infection and spread of virus.
HCLO is a natural substance produced by the body’s own innate immune system (neutrophils) to fight against infections caused by various microorganisms. APR-AOS2020 was designed using APR’s Tehclo™ nanotechnology delivery platform, which “entraps” HCLO in an aqueous solution, enabling it to be inhaled and purifying and stabilizing the natural substance. The mechanism of action of the Sentinox spray is based on the cleansing action of the solution that, supported by the potent antimicrobial activity of HCLO, is able to remove and eliminate in less than a minute viruses and bacteria, including SARS-CoV-2 and its various mutations and variants, without irritating nasal and throat mucosa. Results of in vitro testing with Sentinox conducted by the Institute for Antiviral Research of Utah State University support this mechanism of action and ability to quickly eliminate viruses and bacteria.
Human clinical studies as well as in vitro and in vivo safety tests have demonstrated that APR-AOS2020 has a very good safety profile on various human tissues with a cytotoxicity index of up to 20 times lower than other marketed antimicrobial solutions.
“Based on these encouraging data, we have designed a pivotal, monocentric, randomized, controlled clinical study to assess whether the spray solution, used to irrigate, hydrate and cleanse nasal mucosa for three or five times a day at regular intervals, is safe and effective in patients positive to SARS-CoV-2 with mild symptoms, in addition to the standard therapies, to reduce the nasal viral load – says Professor Giancarlo Icardi, Director of the Hygiene Unit of the IRCCS Policlinico San Martino Hospital in Genoa, lead investigator – Reducing the viral load in the nose, thanks to either the mechanical cleansing mechanism combined with the antimicrobial efficacy of the HCLO, could prevent the insurgence of more severe symptoms and improve the course of the disease in its initial phase, reducing also the risk of spreading the infections to other individuals. If SARS-CoV-2 viral load in the upper respiratory airways is lower, it is likely that the probability of the virus to enter the lower airways damaging lungs is reduced. The nasal spray, when used in the initial phase of infection or after exposure to risk of infection, could reduce the probability of becoming infected, the worsening of symptoms and the spread of the infection to other individuals”.
“We believe that this innovative device, which is designed to be affordable and easy to use, could represent an additional near-term protective option that could be particularly helpful in high-risk environments such as public transportation, shops, schools and other crowded, closed spaces”, says Paolo Galfetti, CEO of APR. “The initiation of this controlled, randomized clinical trial gets us closer to the objective of making this product available before year end specifically for use against COVID-19.”
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