SoftOx Solutions AS: Clinical Trial Application for Dose Escalation / Cystic Fibrosis Phase 2a – Important Milestone Achieved
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.