SOFTOX SOLUTIONS AS: FINAL REPORT REAFFIRMS POSITIVE TOP LINE PHASE 1 RESULTS FOR SOFTOX BIOFILM ERADICATOR

15 Dec 2022 09:09 CET

- This first-in-human clinical study demonstrated that SoftOx Biofilm Eradicator
(SBE) applied on chronic leg wounds was safe and well-tolerated
- There were no statistically significant differences in the evaluation of pain
during and after the wound cleaning procedure comparing SBE with placebo
(Saline).
- Treatment with all SBE formulations consistently reduced the absolute number
of bacteria in the wound compared with pre-treatment
- A dose-dependent reduction in wound size was observed in the multiple-dosing
SBE treatment groups

OSLO – December 15, 2022 - SoftOx Solutions AS ("SoftOx” or the “Company”), a
clinical-stage pharmaceutical and MedTech company based in Norway, announces
that the Company has received the final report and analysis of its Phase 1 study
evaluating the safety and tolerability of SoftOx Biofilm Eradicator (SBE-01)
(EudraCT no. 2021-000314-42), SoftOx’s antimicrobial solution for the treatment
of chronic wounds.

SBE-01 is a first-in-human study investigating the safety, tolerability, and
antimicrobial efficacy of single and multiple doses of SBE in patients with
chronic leg wounds. The Phase 1 study was divided into two parts: a randomized,
blinded, Single Ascending Dose (SAD) phase, followed by an open label, Multiple
Ascending Dose (MAD) phase, where patients were treated once-daily or
twice-daily over five days.

Key findings
The final report reaffirms previous findings that SBE is safe and well-tolerated
by patients suffering from chronic leg wounds. There were no statistically
significant differences in the evaluation of pain during and after the wound
cleaning procedure comparing SBE with placebo. The study found that formulations
of SBE consistently reduced the bacterial burden in the wound compared with
pre-treatment. There was also evidence of wound healing with a reduction in
wound area of between 24 to 36% after just 5 days’ treatment.

Thomas Bjarnsholt, Chief Scientific Officer at SoftOx, said: “According to the
World Health Organization, antimicrobial resistance is one of the largest
threats to human health, which is why it is critical to develop new and
innovative ways to tackle bacterial infections. These results clearly suggest
that the SBE solution is safe and well-tolerated by patients and can
significantly reduce the overall bacterial burden in wounds, ultimately
promoting wound healing. Taken together with previous clinical studies, these
data are early proof-of-concept for the technology as a potential treatment
candidate for patients suffering from chronic wounds worldwide.”

Next steps
Having demonstrated early proof-of-concept for the SBE project and in accordance
with the Company’s corporate strategy, SoftOx will seek a strategic partner to
further develop and advance its wound care segment within acute and chronic
indications.

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

About SoftOx Solutions AS
SoftOx Solutions AS (SoftOx, listed on Euronext Growth Oslo) is a Norwegian
biopharmaceutical and MedTech company based in Oslo, with the goal of reducing
the spread of infection and emergence of antimicrobial resistance. For more
information on SoftOx, visit www.soft-ox.com

About biofilm and antimicrobial resistance
Biofilm in chronic wounds is a cluster of bacteria within a matrix, which makes
it difficult for today’s antibiotics to effectively eradicate the infection in
chronic wounds. Up to 2 per cent of the population of developed countries are
projected to experience a chronic wound during their lifetime. Within organized
biofilms, bacteria are more resistant to antibiotics and immune responses,
making clinical treatment of biofilm infection difficult.

Antimicrobial resistance - significant unmet need
Combination antibiotic therapy and physical removal of biofilms are commonly
used forms of treatment for biofilm-associated infections. Still, there remains
a significant unmet need for new and innovative approaches to tackling biofilm
and multidrug-resistant bacteria. Previous studies have shown that
antimicrobial-resistant bacteria are present in more than 50 per cent of chronic
wounds. According to the World Health Organization (WHO), antimicrobial
resistance is one of the largest threats to human health. In 2019 alone,
antimicrobial-resistant bacteria contributed to 4.95 million deaths worldwide.

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