SoftOx Solutions initiates Phase 1 SIS-02 trial of SIS hypochlorous acid inhalation solution

SoftOx Solutions announced the initiation of its Phase 1 SIS-02 study of SIS hypochlorous acid inhalation solution in healthy volunteers as part of a European Defense Fund-supported effort to develop the inhalation solution as a countermeasure against biological warfare. Earlier this year, the company announced that the Irish Health Products Regulatory Authority had approved the trial.

SoftOx notes that its recently-initiated Phase 2a / proof-of-concept SIS-03 trial of the inhalation solution that includes patients with cystic fibrosis is also underway. The company announced in September 2025 that it would develop SIS for the treatment of lung infections in people with CF.

SoftOx CEO Thomas Bjarnsholt commented, “The initiation of SIS-02 is an important milestone for SoftOx. With trials now underway in both SIS-02 and SIS-03, we are continuing to build the human safety and exposure foundation for SIS as a novel inhaled anti-infective therapy. In parallel with its potential clinical relevance in respiratory infections, we believe SIS may have a role to play in future national biological preparedness and health security strategies.”

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