Oslo / Copenhagen: SoftOx Solutions AS ("SoftOx") today announces that First
Subject First Dosing (FSFD) has been successfully completed in the SIS-03
clinical trial in Denmark. This milestone marks the operational initiation of
the previously approved combined Phase 2a dose-escalation and proof-of-concept
(PoC) study of SoftOx Inhalation Solution (SIS) and represents a key step toward
the Company's next defined value inflection point.
SIS-03 is the regulatory-approved Phase 2a study approved by the Danish
Medicines Agency and structured as a combined clinical program consisting of:
o A dose-escalation component designed to confirm safety and tolerability at
increasing dose levels
o A proof-of-concept (PoC) component in people with cystic fibrosis (CF),
assessing safety at higher doses and generating key data on bacterial load
reduction in the CF airway environment
With first dosing now achieved, the program has transitioned from regulatory
clearance to active clinical execution. Importantly, the study is supplied with
a GMP-manufactured drug product produced from the previously announced GMP drug
substance, confirming full CMC readiness and removing manufacturing risk from
the Phase 2a pathway.
Advancing Toward a Defined Value Inflection Point
The combined study structure enables SoftOx to advance safety confirmation and
early patient evaluation within a single integrated framework. The
dose-escalation phase acts as a gating step toward the PoC component, ensuring a
disciplined and capital-efficient development trajectory.
Data generated from SIS-03 are expected to:
o Confirm tolerability at escalated dose levels
o Provide first patient-based signals on bacterial load reduction in CF
Commercial Relevance
Cystic fibrosis represents a well-established market for chronic inhaled
antimicrobial therapy, with approximately 13,000 patients across the US and
EU4+UK currently receiving treatment, corresponding to an annual market
exceeding USD 600 million.
Beyond CF, the same biofilm-targeting mechanism of SIS is applicable to
significantly larger respiratory indications, including non-CF bronchiectasis,
affecting approximately 445,000 treatable patients across the US and Europe and
representing a multi-billion USD annual market opportunity.
The Phase 2a readout is therefore expected not only to validate the clinical
profile of SIS in CF, but also to materially strengthen the strategic and
commercial positioning of the platform across broader respiratory indications.
Upcoming Milestones
o 1H 2026: Dose-escalation topline data
o Q1 2027: Final Phase 2a PoC readout
These milestones represent clearly defined catalysts for the Company.
CEO Thomas Bjarnsholt comments:
"First dosing in SIS-03 marks the operational start of our combined Phase 2a
program. With regulatory approval secured and GMP manufacturing successfully
completed, we are executing according to plan. The upcoming dose-escalation and
PoC readouts represent important milestones as we advance SIS toward later-stage
development and strategic partnering."
Following FSFD, SoftOx will continue enrolment and dose escalation in accordance
with the approved protocol. Further clinical updates will be communicated to the
market as appropriate.
For more information, please contact:
Ulrik Spork, Chairman of the Board, SoftOx Solutions AS, +45 31 38 83 87
Thomas Bjarnsholt, CEO, SoftOx Solutions AS, +45 20 65 98 88
Mail: ir@soft-ox.com
About SoftOx Solutions AS:
SoftOx Solutions AS (ticker: SOFTX) is a clinical-stage pharmaceutical company
listed on Euronext Growth Oslo. The company is developing highly effective
pan-antimicrobial pharmaceuticals targeting bacteria, viruses, and fungi. The
technology is based on extensive research and development in partnership with
leading Nordic research institutes.