PR89484

BALERNA, Switzerland, May 14, 2021 /PRNewswire=KYODO JBN/ --

Product recently cleared in EU as Class III medical device

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.

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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(TM) 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. For more information,

please visit: https://www.apr.ch/ [https://www.apr.ch/]

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.

Logo -

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Contacts:

APR Applied Pharma Research s.a.

Paolo Galfetti, CEO

info@apr.ch [mailto:paolo.galfetti@apr.ch]

+41 91 6957020

[1] https://link.springer.com/article/10.1007/s00405-021-06644-5

Source: APR Applied Pharma Research s.a.