SoftOx Solutions AS — Regulatory Filings 2021

Mar 15, 2021

SOFTOX SOLUTIONS AS: DANISH MEDICINES AGENCY APPROVES FIRST-IN-HUMAN CLINICAL STUDY FOR SOFTOX WOUND TREATMENT AGENT FOR INFECTIONS IN CHRONIC WOUNDS, BIOFILM ERADICATOR (SBE)

SOFTOX SOLUTIONS AS: DANISH MEDICINES AGENCY APPROVES FIRST-IN-HUMAN CLINICAL STUDY FOR SOFTOX WOUND TREATMENT AGENT FOR INFECTIONS IN CHRONIC WOUNDS, BIOFILM ERADICATOR (SBE)

The Danish Medicines Agency (DKMA) has authorised the “SBE-01” clinical trial on medicinal products. The authorisation is given pursuant to § 88(1) of the Danish Medicines Act.1.

This rapid approval by DMA in less than 3 weeks is exceptionally fast and demonstrates the completeness and quality of our documentation and proposed study design, says Glenn Gundersen, Medical Director in SoftOx Solutions AS. This is the first-in-man (phase I) study with our lead wound care product, SBE, designed to treat infected chronic wounds. The study will establish a tolerable dose and treatment schedule for SBE to be able to develop it into an effective infection-treatment solution in problematic, non-healing wounds.

This approval represents an important milestone for SoftOx Solutions AS and is of crucial importance for the further development of an effective infection treatment of problematic wounds, where there is an unmet medical need. It is also an important step forward for the company's collaboration and funding partners, such as University of Copenhagen, Bispebjerg University Hospital, US Naval Medical Research Center (NMRC) under Medical Technology Enterprise Consortium (MTEC) and The Research Council of Norway.

The SBE-01 study will commence as soon as permission has also been granted by the relevant Scientific Ethical Committee.

SBE-01: EudraCT no. 2021-000314-42.

For further information, please contact:

Geir Almås, CEO of SoftOx Solutions AS, or

Glenn Gundersen, Medical Director in SoftOx Solutions AS

Mail: ir@soft-ox.com

Mobile: +47 977 59 071

About SoftOx Solutions AS

SoftOx Solutions AS (SoftOx, listed on Euronext Growth Oslo) is a Norwegian

MedTech 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