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SoftOx Solutions är ett norskt medicintekniskt bolag. Bolaget har utvecklat en egenpatenterad lösning baserad på ättiksyra för behandling av kroniska sår hos patienter. Lösningen används för att eliminera infektioner i samband med biofilmer, vilket består av olika kluster av bakterier. En del av läkemedelsutvecklingen sker i samarbete med övriga forskningsinstitut. SoftOx Solutions etablerades under 2012 och har sitt huvudkontor i Oslo.


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2021-10-06 15:13:37
OSLO - October 6, 2021: SoftOx Solutions AS (SoftOx) have announced today that
the Danish Medicines Agency (DKMA) approved the Phase 1 clinical trials for
SoftOx Inhaled Solution (SIS), an aerosolized antimicrobial product intended for
the treatment of upper respiratory tract infections (e.g., influenza and common
colds) and lower respiratory tract infections (e.g., pneumonia and bronchitis).

"SIS would be a game changer in the treatment of viral and bacterial infections
in the respiratory tract", says CEO Geir Almås at SoftOx Solutions.

"Soon commencing human trials"
The Phase 1 trial is part of a development program for the use of SIS in the
treatment of respiratory tract infections starting with SARS-CoV-2 (COVID-19)
infections. This trial is scheduled to commence in autumn 2021, in Denmark.

"We are pleased to have satisfied the Danish Medicines Agency requirements, and
that we will soon commence this first-in-human trial of SoftOx Inhaled
Solution", says Dr Christopher Burton, Chief Medical Officer for SIS.

SIS is a stabilised solution of hypochlorous acid that can be aerosolised and
inhaled. The antimicrobial properties of hypochlorous acid are well described,
and endogenous production of hypochlorous acid is one of the key elements
involved in host immunity from infectious disease.

"Hypochlorous acid is extremely effective in killing viruses and bacteria in
vitro. Up until now, the problem has been maintaining hypochlorous acid in a
stable form until delivery to the target tissues," says Dr Burton.

First major step
SIS-01 (EudraCT No.: 2020-004462-19) is a single-centre, randomised,
double-blind, placebo-controlled study, the study will explore the safety and
tolerability of single and multiples doses of inhaled nebulised SIS in healthy

"This is the first major step in the development of a pharmaceutical for
treatment of the respiratory tract based on SoftOx Solutions proprietary
technology for the stabilisation of hypochlorous acid," says Almås.
"SIS would be a game changer in the treatment of viral and bacterial infections
in the respiratory tract. SIS is particularly relevant in the context of the
current pandemic and for future epidemics and pandemics, and the emerging threat
of antimicrobial drug resistance", continues Almås.

For further information, please contact:
CEO Geir Almås of SoftOx Solutions AS, or
CMO, SIS, Christopher Burton
Mail: ir@soft-ox.com
Mobile: (+47) 948 59 599

The information included in this announcement is defined as inside information
pursuant to MAR article 7, and is publicly disclosed in accordance with MAR
article 17. The announcement is made by the contact person.

About SoftOx Solutions AS
SoftOx Solutions AS (Softx, listed on Euronext Growth Oslo) is a Norwegian
BioTech company based in Oslo with the aim of helping to combat major threats to
human health, namely the emergence of antimicrobial resistance (AMR), biofilm
infections in chronic wounds and the spread of viruses. For more information on
SoftOx, visit www.soft-ox.com