According to SoftOx Defense Solutions, the Irish Health Products Regulatory Authority has approved a clinical trial application for the company’s SIS-02 Phase 1 study of SIS hypochlorous acid inhalation solution in healthy volunteers. SoftOx recently announced that Danish authorities cleared a Phase 2 trial of the inhalation solution in healthy volunteers and in patients with cystic fibrosis. SoftOx announced results from a previous Phase 1 trial of the inhalation solution in 2022.
The company announced in September 2025 that it would conduct a new Phase 1 trial as part of its refocus on development of the inhalation solution for the treatment of chronic lung diseases in CF patients after having previously focused on development of SIS for the treatment of ventilator associated pneumonia. SoftOx says that it is continuing to develop SIS as a military countermeasure as well as for the treatment of chronic lung infections caused by a wide range of pathogens.
SoftOx CEO,Thomas Bjarnsholt commented, “The approval of SIS-02 by HPRA in Ireland is a key execution milestone for SoftOx. It establishes the human safety and dosing foundation of our inhalation platform and, together with our already approved Phase 2a program, enables us to advance civilian development while progressing preparedness-oriented and defense-relevant applications in parallel.”
Read the SoftOx Defense Solutions press release
