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Beskrivning

LandNorge
ListaMERK Equities
SektorHälsovård
IndustriMedicinteknik
SoftOx Solutions är ett norskt medicintekniskt bolag. Bolaget har utvecklat en egenpatenterad lösning baserad på ättiksyra för behandling av kroniska sår hos patienter. Lösningen används för att eliminera infektioner i samband med biofilmer, vilket består av olika kluster av bakterier. En del av läkemedelsutvecklingen sker i samarbete med övriga forskningsinstitut. SoftOx Solutions etablerades under 2012 och har sitt huvudkontor i Oslo.
2022-05-19 10:30:01
OSLO - May 19, 2022: SoftOx Solutions AS ("SoftOx" or the "Company"), a
clinical-stage pharmaceutical and medtech company based in Norway, today
announced top line results from its Phase 1 study evaluating SoftOx Inhalation
Solution (SIS). SIS is a novel aqueous formulation of hypochlorous acid (HOCl),
a biological oxidant with broad spectrum antimicrobial (antiviral and
antibacterial) properties.

In this Phase 1, first-in-human study, nebulised SIS achieved the primary
objective of safety and tolerability in healthy subjects. There were no observed
local tolerability issues, no adverse effects on pulmonary function, and no
serious adverse events.

"We are highly encouraged by these Phase 1 results demonstrating an acceptable
safety and tolerability profile for a potential future inhaled antiviral
treatment", says Dr Christopher Burton, Chief Medical Officer for SIS. "This
study paves the way forward for the future clinical development of SIS within
infectious disease indications in the upper and lower respiratory tract."

SIS-01 is a first-in-human study investigating the safety and tolerability of
single and multiple ascending doses of nebulised SIS to healthy subjects. The
randomized, double-blind trial was the first systematic, placebo-controlled
study investigating the safety and tolerability of inhaled HOCl in humans. A
total of 57 healthy volunteers were randomised to receive SIS formulations of up
to 100 µg/ml HOCl, four times daily for five days, or a matching placebo
regimen.

"SIS has the potential to be a breakthrough in respiratory treatment", stated
CEO Geir Almås of SoftOx, "the broad spectrum antimicrobial effect of SIS
obviates the need for expensive diagnostic testing which can also delay the
start of treatment, and would represent a paradigm shift in the management of
respiratory infections."

Data from the study demonstrates that an aqueous formulation of HOCl can be
administered to the respiratory tract as an aerosol, as evidenced by
dose-response effects on safety parameters, which were predominantly mild, even
in the most intensive dosing regimen.

With these positive results from the Phase 1 study, SoftOx will continue Phase 2
clinical development of SIS. The company is already in the process of preparing
Phase 2 documentation and is engaged in dialogue with the European Medical
Association.

For more information about the SIS-01 study, please visit clinicaltrials.gov and
reference identifier: NCT05188638.

For further information, please contact:
Geir Almås, CEO of SoftOx Solutions AS, or
Christopher Burton, CMO, SIS, SoftOx Solutions AS
Mail: ir@soft-ox.com
Phone: Front Desk: (+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 IR responsible.

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