SoftOx pivots clinical focus to chronic lung diseases

SoftOx Solutions AS announced a shift in its initial clinical focus for its SoftOx Inhalation Solution (SIS) to chronic lung diseases, specifically cystic fibrosis (CF) and non-cystic fibrosis bronchiectasis (NCFB), over ventilator-associated pneumonia (VAP). This strategic refinement aims to establish a stronger and broader proof-of-concept (POC) for SIS, without impacting previously announced budgets and timelines. The company plans to submit the clinical trial application by end of September 2025, with study initiation in Q1 2026.

The POC trial will first evaluate SIS safety in healthy volunteers at escalating doses, followed by demonstrating bacterial load reduction in patients with chronic airway infections. Expected readouts from dose escalation are in H1 2026, with the PoC study concluded in Q1 2027. This 12-month study will require a €7-8m investment.

SoftOx estimates the addressable market for SIS in CF to be above $600m, and for NCFB, potentially up to ~$5bn. The company believes positive data will make SIS an attractive partnering candidate for global pharmaceutical companies. An investor update is scheduled for September 8th, 2025.