SoftOx Solutions AS — Regulatory Filings 2021

Oct 6, 2021

SOFTOX SOLUTIONS: APPROVAL RECEIVED FROM DANISH MEDICINES AGENCY TO COMMENCE FIRST CLINICAL TRIAL OF SOFTOX INHALED SOLUTION (SIS)

SOFTOX SOLUTIONS: APPROVAL RECEIVED FROM DANISH MEDICINES AGENCY TO COMMENCE FIRST CLINICAL TRIAL OF SOFTOX INHALED SOLUTION (SIS)

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 subjects.

“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