Clinical-stage pharmaceutical company SoftOx Solutions AS (Euronext Growth Oslo:SOFTX) announced on Tuesday that the first patient has been dosed in the proof-of-concept phase of its SIS-03 clinical programme. The Phase 2a patient trial is evaluating SoftOx Inhalation Solution (SIS) as an inhaled anti-infective treatment for chronic airway infections.

The dosing follows completion of SIS-03's dose-escalation phase in healthy volunteers and a positive safety review that reported no serious adverse events or severe tolerability issues. The patient phase will assess clinical and microbiological signals, including potential reductions in bacterial load in the airways.

Conducted with Rigshospitalet in Copenhagen, the trial is expected to enrol 15 to 25 patients and conclude in the first half of 2027. SIS-03 is separate from the company's SIS-02 programme, which is evaluating SIS in healthy volunteers in a biodefence context.

SoftOx estimates that about 13,000 cystic fibrosis patients across the US and EU4+UK receive chronic inhaled antibiotic therapy, representing an annual market exceeding USD600m. The company also believes SIS could have relevance in non-cystic-fibrosis bronchiectasis, which affects approximately 445,000 patients and represents a potential market exceeding USD5bn.