SoftOx Solutions AS ("SoftOx") is pleased to announce that it has formally
submitted a clinical trial application (CTA) to the Danish Medicines Agency for
approval of its upcoming dose-escalation / Phase 2a clinical study in people
with cystic fibrosis (CF).
This submission marks a significant milestone in SoftOx's clinical development
strategy and is the decisive step toward initiating human efficacy testing of
SoftOx's inhalation solution (SIS). It culminates the extensive preclinical work
and strategic refinement of the Company's clinical focus. The planned Phase 2a
trial will evaluate safety at higher doses and provide important data on
bacterial load reduction in people with CF, where unmet medical need remains
high.
The CTA filing is a key step on the Company's path toward commercialization in
cystic fibrosis, targeting ~13,000 addressable patients in the US and Europe
with a market potential of more than USD 600 million. It also paves the way for
expansion into related indications such as non-CF bronchiectasis, targeting
~445,000 addressable patients in the same regions with a market exceeding USD 5
billion.
The study is expected to start in Q1 2026, subject to approval. Positive
progress and data from the study will further enhance SoftOx's attractiveness as
a potential partner for global pharmaceutical companies.
CEO Thomas Bjarnsholt comments:
"This submission underlines our commitment to advancing SoftOx's pipeline and
delivering on our strategic goals. It is a key inflection point for the company,
demonstrating progress toward addressing significant unmet medical needs."
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.