Initiated clinical trial with novel nasal spray codenamed APR-AOS2020 in patients with mild COVID-19

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.[1]

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."

About APR Applied Pharma Research s.a. ("APR")

APR is an independent pharma company headquartered in Switzerland with subsidiaries in Italy and Germany focused, since more than 25 years, in the development and commercialization of products intended to improve the quality of life of patients and families dealing with serious diseases of high medical need. APR's portfolio includes products for the treatment of rare or niche diseases which are commercialized in about 50 countries worldwide either directly or through licensing and distribution agreements with selected partners. The pipeline includes products at different stage of development concentrated in 3 selected therapeutic areas: inherited metabolic recessive diseases, cancer supportive care and skin rare diseases.

About APR-AOS2020

APR-AOS2020 is an acid-oxidizing solution (AOS) containing hypochlorous acid at 0,005% certified and authorized in Europe on March 5th 2021 as Class III Medical Device (Certificate Nr. EPT 0477.MDD.21/4200.1 having provisional name Sentinox). The device is intended for irrigation, cleansing and moistening of the nasal cavities and is indicated for (i) reducing the risk of infections caused by bacteria and viruses, including SARS-CoV-2, by lowering the nasal microbial load, (ii) symptomatic nasal care and (iii) nasal care in case of minor lesions/alterations of the nasal mucosa.