SoftOx Solutions AS — Regulatory Filings 2021

Oct 19, 2021

SOFTOX SOLUTIONS: FIRST SUBJECT ENROLLED IN TRIAL OF SOFTOX INHALED SOLUTION (SIS)

SOFTOX SOLUTIONS: FIRST SUBJECT ENROLLED IN TRIAL OF SOFTOX INHALED SOLUTION (SIS)

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

Mail: ir@soft-ox.com

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