SoftOx Solutions AS (SoftOx) have announced today that the first subject has
received SoftOx Inhaled Solution (SIS), in the first-in-human Phase 1 trial. SIS
is an aerosolized pan-antimicrobial product intended for the treatment of upper
and lower respiratory tract viral and bacterial infections. The trial is part of
a development program for the use of SIS in the treatment of SARS-CoV-2
(COVID-19) and other respiratory tract infections, and is a collaboration
between SoftOx and University of Copenhagen.
The first subject received a single administration of low dose SIS. Healthy
volunteers will receive three escalating doses of SIS or placebo, nebulised as a
single dose once, twice or four times daily for 5 days.
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.
"The SoftOx technology platform is a stabilised formulation of hypochlorous acid
that permits aerosolization using a jet nebulizer" says Dr Christopher Burton,
Chief Medical Officer for SIS. "The SIS-01 trial will evaluate safety and
tolerability of three different concentrations administered up to four times
daily, which will provide the basis for future studies evaluating efficacy in
COVID-19 and other respiratory tract infections."
SIS-01 (EudraCT No.: 2020-004462-19) is a single-centre, randomised,
double-blind, placebo-controlled, study will explore the safety and tolerability
of single and multiples doses of inhaled nebulised SIS in healthy subjects.
"This is another important milestone in the development of a pharmaceutical
product for which there is a huge unmet need," says Geir Almås, CEO.
"Society faces a growing threat of new emergent viral strains and increasing
antimicrobial resistance to currently available treatments. SIS has the
potential to fill that need."
For further information, please contact:
CEO Geir Almås of SoftOx Solutions AS, or
CMO, SIS, Christopher Burton
Mobile: (+47) 948 59 599
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