SoftOx submits key clinical trial application for cystic fibrosis drug

SoftOx Solutions AS has submitted a Clinical Trial Application (CTA) to the Danish Medicines Agency for its upcoming dose-escalation / Phase 2a clinical study in cystic fibrosis (CF). This submission marks a significant milestone, setting the stage for human efficacy testing of its inhalation solution (SIS). The Phase 2a trial will evaluate safety at higher doses and provide data on bacterial load reduction in CF patients.

The CTA filing is a key step towards commercialization in cystic fibrosis, targeting approximately 13,000 addressable patients in the US and Europe with a market potential exceeding $600m. It also paves the way for expansion into related indications such as non-CF bronchiectasis, which targets around 445,000 addressable patients in the same regions with a market value over $5bn.

The study is expected to commence in Q1 2026, pending approval. CEO Thomas Bjarnsholt emphasized that this submission demonstrates progress towards addressing significant unmet medical needs.